A qualitative study exploring medication management in people with dementia living in the community and the potential role of the community pharmacist

Abstract Background The prevalence of dementia is increasing rapidly. People with dementia may be prescribed complex medication regimens, which may be challenging for them and any carers involved to safely manage. Objective To describe and understand the key challenges, in relation to medication issues, experienced by people with dementia and their informal carers dwelling in the community and the potential role of community pharmacists. Design Qualitative semi‐structured interviews. Participants People with dementia, informal carers and health and social care professionals (HSCPs). Results Thirty‐one participants (eleven informal carers, four people with dementia and sixteen HSCPs) were interviewed. Three key themes were identified: the key challenges, improving medication management and the role of pharmacists. The caring role commonly included responsibility for medication management which created both practical problems and an emotional burden. This burden was worsened by any difficulty in obtaining support and if the person with dementia was on a complex regimen. Participants believed that the process could be improved by coordinated and on‐going support from HSCPs, which should focus on the informal carer. Medication reviews, particularly when conducted in the home environment, could be helpful. Conclusion Medication management for people with dementia living in the community is a complex process, and informal carers have a key role, which they frequently find challenging. Community pharmacists could have an enhanced role in this area, but would need to work within a more multidisciplinary environment outside the pharmacy.

amongst others. [3][4][5][6] The cognitive impairment characteristic of dementia may result in a lack of capacity to safely self-administer medication. 7,8 Despite people with dementia being particularly susceptible to adverse drug events, they are commonly prescribed complex medication regimes and on average receive five different medicines. 7,9 Medication management "is the entire way that medicines are selected, procured, delivered, prescribed, administered and reviewed to optimize the contribution that medicines make to producing informed and desired outcomes of patient care". 10 With increasing cognitive impairment, the core symptom of dementia, medication management is often shifted from the personal responsibility of the person with dementia to the control of formal (paid) or informal (family) carers particularly with complex regimens. [11][12][13][14][15] Informal carers often have a key role in ensuring safe and effective medication use as they may conduct up to 10 medication management activities every day, including awareness of and managing side-effects, and decisions to administer medication. 16,17 Previous research has identified the role of informal carers as advocates and their potential contribution to patient safety. 18 Unlike health professionals, family and friends who are informal carers may not receive any training or have access to evidence-based information to appropriately support medication management. 17,19 In fact, informal carers may not feel equipped for such an augmented role which they can find burdensome and stressful and this in turn may affect the informal carer's and the person with dementia's quality of life. [20][21][22][23][24] Without the support and collaboration of health professionals involved, informal carers may struggle to adequately support medication management especially of complex regimes. 8 However, some healthcare professionals lack time and awareness of the administration practicalities and the realities of informal carers and people with dementia. 25,26 Furthermore, the information about medication regimens, provided by health-care professionals, can be complex and sometimes is not directly communicated to the informal carer due to the restriction of confidential information. 17,19,26 The role of community pharmacists is changing from being focused on the supply of medicines to providing clinical services. 27,28 These services are focused on helping patients obtain the optimal benefit from prescribed medication by advising other clinicians and working directly with patients and others. [29][30][31][32] The change in role is supported by national and international policy. 29,33 The available literature argues that community pharmacy services available for people with dementia are poorly developed and the need for further research on ways to optimize medication management in people with dementia living in the community has been identified. 25,34 It is important then to explore the perspectives of the key stakeholders, including informal carers and people with dementia, to understand how community pharmacists can support people with dementia living in the community with safe medication management. The objectives of the study were to describe and understand the key challenges, in relation to medication issues, experienced by people with dementia and their informal carers dwelling in the community, and the potential role of community pharmacists.

| Design
An exploratory qualitative study design that followed Consolidated Criteria for Reporting Qualitative studies (COREQ) guidelines 35 was employed (see appendix for further details). A focus group conducted at the Alzheimer's Society and involving informal carers had previously identified the need for research in this area. 26

| Participants and recruitment
Participants were recruited from the Alzheimer's Society, Dementia UK, local General Practice (GP) surgeries, professional networks and local dementia support groups (including a support group for people with dementia from the Black and Minority Ethnic [BME] community in Yorkshire). The institutions were contacted by LA and IM via telephone and email and were enquired about their willingness to collaborate in advertising the study. Recruitment was also conducted through snowball effect as contacts were requested to suggest other people with dementia, informal carers and HSCPs who might be willing to take part in this study.

| Data collection
Semi-structured face-to-face interviews were conducted. Two interview guides were used: one for people with dementia and their informal carers and one for HSCPs (see appendix for further details). This was the selected type of interview as it gives participants the opportunity to expand their answers freely and to provide in-depth reflections about their lived experiences. Furthermore, it allowed obtaining data that were suitable for conducting a Framework analysis. On three occasions, both the informal carer and the person with dementia were together in the room during the interview. This allowed the person with dementia to provide further insight into what the informal carer was saying. Each interview lasted between 30 and 60 minutes.
Interpreters from the same community were used for all the interviews with informal carers from the BME community.

| Inclusion criteria
Informal carers were eligible if: • They had provided or still provide some sort of assistance with medication management to a person who has been diagnosed with dementia and is living in the community; • Did not receive any sort of payment (excluding receipt of carers' allowance).
HSCPs were eligible if: • They had been in contact with or had been providing assistance to people with dementia

| Data analysis
A qualitative framework analysis was undertaken in order to explore the experiences and perspectives of the participants. Framework analysis, which has been specifically designed for applied qualitative research that commences deductively from specified aims and objectives, was used to organize and make sense of the data. 36,37 NVIVO software was used to manage the data.
The transcripts were transcribed verbatim. TM and IM independently reviewed the transcripts. Disagreements on the interpretation and analysis of the data were then discussed between TM and IM. Any disagreements or differences in interpretation of the data between TM and IM were resolved, as necessary, with discussions involving the wider team (with AH the final arbiter) until consensus was achieved. A systematic cross-comparison analysis was undertaken by TM, and reviewed by IM to identify the similarities and differences between the different participants and to develop a set of themes which represent the whole corpus of data. TM and IM then discussed and agreed the final structure of the matrix for the analysis.

| RESULTS
Thirty-one participants, eleven informal carers, four people with dementia, sixteen HSCPs (four GPs, five nurses, three social care professionals [paid formal carers] and four community pharmacists), were interviewed. Three main themes were identified. Key challenges experienced by informal carers and people with dementia (the caring role, the challenges of the condition), improving medication management in people with dementia (empowerment and communication from health professionals) and the role of pharmacists.

| Key challenges experienced by informal carers and people with dementia: the caring role, the challenges of the condition
Interviews with informal carers and people with dementia provided information on the challenges that they experience in relation to medication management. Nearly half of the carers reported that they had no problem in terms of the practicalities of managing the medication.
Although it is a complex process, by adopting an organized routine, carers reported that the practical aspects of managing medication did not have any impact on their lives:

| Improving medication management in people with dementia: empowerment and communication from health professionals
All groups (people with dementia, informal carers and HSCPs) identified that people with dementia and their informal carers needed more support with medication management. Medication management is frequently solely dependent on informal carers, and therefore, targeting them is the best way to improve the process: However, this topic needs to be addressed carefully as the information needs to be tailored to person with dementia and their informal carer. It is important to not only provide the right instructions for the right illness but make sure that the person has the ability to understand the message (as the earlier quote from the GP pp15 also In addition, medication reviews were viewed as having a potentially positive impact, but clinicians may lack the time to conduct them adequately: In a 20 minute appointment and looking at their medication is just one part of that…most people will probably say, "No, no, its fine, I'm taking them". But actually, you know, I

| The role of pharmacists
HSCPs identified the role of pharmacists in giving advice on medication.
However, informal carers and people with dementia tended to focus on practical aspects of the role, such as home delivery of medication, and viewed their role in terms of the supply of medication without mentioning or indeed knowing about the clinical roles pharmacists can provide: Well, it's got to be the doctors, hasn't it, and nurses… they're the ones, aren't they (that provide support for medication management)…rather than the pharmacists…they just provide it (medication), don't they.

| DISCUSSION
Medication management for people with dementia living in the community is often a very complex task and supported by a triad of the person with dementia, informal carers and various HSCPs. Informal carers have a pivotal role, but yet frequently find managing the medication of someone with dementia challenging. Indeed, even carers who stated that they had everything under control identified a 'duty to cope' and associated emotional burden. This echoes the findings elsewhere where informal carers identified that any failure to cope would be viewed as their fault. 26,38,39 This challenge increased as the complexity of the regimen increases and if the carers lacked adequate support, again echoing previous research. 11,16,25,26 Limited English proficiency also increased the difficulties. 5 The challenges associated with medication management for people with dementia, their informal carers and the wider society can have potentially serious consequences. There is an increased risk of people with dementia experiencing a medication error, as clearly seen in the accounts from both HSCPs and carers, and previously identified. 40 Making sure that their loved one takes the right medication at the right time places a significant emotional burden on the informal carer, which is not always acknowledged by the HSCP. Additionally, if informal carers fail to cope, this has wider implications for society because further resources such as admission to residential care may be required. 21 Other research on the challenges for informal carers in the management of Behavioural and Psychological Symptoms of Dementia (BPSD) also found a 'sense of shame' if the carers failed to cope and that the burden is often hidden from HSCPs. 38,39 As far as we are aware, this is the first study that has focused on the barriers to community pharmacists supporting informal carers of people with dementia. Other studies have found barriers to a more clinical role for community pharmacists in the management of BPSD 28 and pain in people with dementia. 41 Similar to our research, the pharmacists in these studies believed that a lack of training and multidisciplinary working and lack of access to clinical records inhibited their input. 28,41 Equally importantly, we found, like other research, that informal carers tended to view the role of pharmacists in terms of medication supply. 5,26 Other studies have identified high levels of polypharmacy with potentially inappropriate prescribing in people with dementia ranging from 22% 4 to 81.5% of participants. 6 We found that medication review focussing on simplifying the regimen might be helpful, particularly if delivered in the home environment. However, a systematic review found that pharmacist-led chronic disease management increased the complexity of the medication regimen. 42 Ultimately, it is essential that HSCPs adopt a person-centred approach and pay attention to the challenges that informal carers and people with dementia face. This should include exploring ways to reduce any burden on informal carers associated with managing medication.
More generally, medicine optimization -defined as a 'personcentred approach to safe and effective medicines use, to ensure people obtain the best possible outcomes from their medicines' -has been identified a key priority within primary care. 43,44 Further research on how to improve outcomes from medication and deliver medicine optimization is needed. 44 Deprescribing which is considered to be 'the process of withdrawal of inappropriate medication, supervised by a health-care professional with the goal of managing polypharmacy and improving outcomes' may represent a promising approach to medicine optimization. 45 However, evidence on the impact of deprescribing in older people is equivocal and further evidence from controlled studies is required. 46

| Implications for clinicians and policymakers
Clinicians and policymakers need to be aware of the challenges involved and that even informal carers who do not report difficulties may be experiencing an emotional burden. Evidence-based guidelines need to consider this burden, which is worsened as the complexity of the regimen increases. There is a potential for community pharmacists to work outside the 'four walls' of the community pharmacy in order to support people with dementia and their informal carers manage their medication. 47 This 'work without boundaries' should include medication reviews in the patient's home, needs full access to clinical records and be coordinated with other medication optimization activity. 48 Whilst home-based medication reviews are occurring in some areas, this research found inconsistencies between regions. This need to review medication in the patient's own home would equally apply to practice-based pharmacists.

| Strengths and weaknesses
The study has a number of potential strengths. Data were triangulated from the perspectives of different HSCPs, informal carers and people with dementia. Participants were recruited from various locations and data saturation was achieved for the complete set of interviews, based on criteria from Fusch et al. 49 Like all research, there are limitations. Findings are context-bound to the participants and study setting, like all qualitative research. 50 Although we believe that the testimonies from the participants were particularly rich in content, as data were obtained from face-to-face interviews, we cannot avoid the possibility that participants may have given socially desirable responses. Only a limited number of participants from the BME community were interviewed.

| Future research
Further research would benefit from exploring the perspectives of a more diverse sample including people from the BME community; this study only included people from the South Asian BME community, and people with dementia living alone. A future project could also fol- They therefore need additional support, which needs to be recognized by commissioners of services. Appropriate care pathways should be established to provide this support; community pharmacists can be a key element of these pathways. Are you happy for me to begin?

APPENDIX Demographic Details of Participants
Can you tell me a bit about yourself? For example, do you have family or do you work?
Can you describe what a typical day involves for you?
The next few questions are going to be in regard to medication.
(If people with dementia) Can you describe to me any practical issues/concerns (if any) you find with taking medication?
(If carer) Can you describe to me any practical issues/concerns (if any) you find with assisting somebody with their medication?
Can you describe to me any strategies you use to organize medication?
Prompt: From sorting your medication to taking it or assisting someone to take it; are there any particular methods/procedures you use to do this?

In this next section, I am going to ask a few questions with regard to taking (if interviewing the person with dementia) or assisting somebody
(if the carer) in taking medication. I want to remind you that these questions are to help us better our understanding of how people feel about medication. Your replies will be treated so that no one will be able to identify that these are your answers.
(If person with dementia) Can you tell me about a time, if any, you have decided not to take your prescribed medication?
(If carer) Can you tell me about a time, if any, you have chosen to not give prescribed medication to your (whatever the relationship)?
Prompt: Do you think that people should always take their prescribed medication?
What would you describe as the benefits of taking medication?
Prompt: In your opinion, are there any benefits to not taking medication?
Can you think of any reasons why people would not take their prescribed medication?
The next section of questions will be about your experiences with medication: In your opinion, does managing your medication affect your daily life?
Have you had any changes to medication over time?
If yes, can you tell me a bit about that and how it made you feel?
If no, do you think change in medication over time would have an effect on someone in your situation? If yes, in what way?
(If carer) Have you become more involved in assisting in the organization of medication?
If yes, how did that make you feel?
We are moving onto the last section of the interview now; this section is to do with your opinions and experiences with health-care professionals: Can you tell me about the experiences you have had with health-care professionals (i.e. GPs, pharmacists, social care workers) over the past couple of years?
Prompt: Have you had any notable experiences with health-care professionals?
Can you describe to me your feelings about the level of support you have in regard to health-care professionals helping you with medication?
How do you think health-care professionals could improve support to people with dementia and their carers when it comes to helping with medication management?
Prompt: Do you need support from health-care professionals in regard to medication management? If yes, what kind of support would be helpful?
How do you feel about the future in terms of support from health-care professionals in helping with medication?
Prompt: Do you think health-care professionals need to be more involved in supporting people with dementia and their carers manage their medication?
Prompt: What health-care professional do you think would be most helpful in offering this support? Do you feel that assisting/reviewing medication for people with dementia and their carers is a part of your role?
Prompt: Can you describe any facilitators or barriers that help or hinder you from assisting/reviewing medication?
The next couple of questions are going to be about compliance/adherence to medication.
Can you tell me whether you have ever experienced patients who have dementia not adhere to prescribed medication?
Prompt: If yes, can you tell me a bit about this and how did you manage this?
What do you believe could be the potential reasons for non-adherence/non-compliance in people with dementia/their carers?
The last section of the interview focuses on your opinions about current practice.
Can you tell me about your beliefs on the level of support available for people with dementia and their carers in regard to medication management?
How, in your opinion, do you think the service could improve?
Prompts: In order to make any improvements, what should take place?
In your opinion, can you describe to me the role that community pharmacy plays in medication management in people with dementia? An exploratory, qualitative study was conducted employing semi-structured interviews. Data were analysed using framework analysis.

How were participants selected?
Informal carers were eligible if: • They had provided or still provide some sort of assistance with medication management to a person who has been diagnosed with dementia and is living in the community; • Do not receive any sort of payment (excluding carers' allowance).
Health and social professionals were eligible if: • they had been in contact with or had been providing assistance to peo-

What did the participants know about the researcher?
The participants knew that IM of Aston University was leading the research and it was funded by Pharmacy Research UK and that LA and TM were research assistants and that AH was an academic from Hull University.

What characteristics were reported about the interviewer/facilitator?
LA and TM reported that they were research assistants conducting interviews in this area with little clinical knowledge; AH reported that she was an academic from Hull University.

Was anyone else present besides the participants and researchers?
No-one else was present except for interviews pp 025, 026 and 027 when a translator/interpreter from the same community was present. The interpreter did not hold an official qualification however they were from the same background and spoke the same language as the participants.
The interpreters had been involved in previous studies where they have translated and were identified by an academic from the same community.
He was confident of the accuracy of the translation and the results were consistent with other findings.

What are the important characteristics of the sample?
Informal carers were eligible if: they had provided or still provide some sort of assistance with medication management to a person who has been diagnosed with dementia and is living in the community and did not receive any sort of payment (excluding carers allowance).
Health and social professionals were eligible if they had been in contact with or had been providing assistance to people with dementia.

Were questions, prompts, guides provided by the authors? Was it pilot tested?
The

Were repeat interviews carried out?
No interviews were repeated.

Did the research use audio or visual recording to collect the data?
A Dictaphone was used to record the interviews. Data were transcribed verbatim.

Were field notes made during and/or after the interview or focus group?
Additional notes were made during the interviews.

What was the duration of the interviews or focus group?
The length of each interview was not formally recorded. However, on discussion with LA, TM and AH, the interviews with HSCPs lasted on average approximately 20 to 30 minutes; the interviews with carers/PwD 60 to 90 minutes.

Was data saturation discussed?
Data saturation was reached and discussed amongst all co-authors.

Were transcripts returned to participants for comment and/or correction?
Transcripts were not returned to the participants, but potential themes were discussed between all co-authors.

How many data coders coded the data?
TM and IM independently reviewed the transcripts. Disagreements on the interpretation and analysis of the data were then discussed between TM and IM until consensus was achieved. A systematic cross-comparison analysis was undertaken by TM, and reviewed by IM to identify the similarities and differences between the different participants and to develop a set of themes which represent the whole corpus of data. TM and IM then discussed and agreed the final structure of the matrix for the analysis.

Did authors provide a description of the coding tree?
No.

Were themes identified in advance or derived from the data?
Themes were derived from the data. Three key concepts were elicited from the data with subthemes within these three themes.

What software, if applicable, was used to manage the data?
NVIVO software was used to manage the data.

Did participants provide feedback on the findings?
Participants did not provide feedback.

Were participant quotations presented to illustrate the themes/ findings? Was each quotation identified?
Extracts presented in the results section were drawn directly from the transcripts, which are recordings of the interviews.

Was there consistency between the data presented and the findings?
Yes there was consistency between the data presented and the findings.

Were major themes clearly presented in the findings?
Three key concepts were elicited from the data with subthemes within these three themes, and all three themes were discussed in the results section.

Is there a description of diverse cases or discussion of minor themes?
Yes, diverse cases have been discussed and the differences between the interview data from the carers and HSCPs. When relevant, minor themes were discussed.