A. Method and Participant Demographics
The empirical data drawn on here were generated through a tripartite data collection process exploring carers' experiences of access to, and the regulation of, health and social care support services for people with dementia. The findings are drawn from two inter-linked research projects, which included a multi-method online and paper questionnaire (
n = 185), followed up with four focus groups (
n = 15) and eleven in-depth interviews.
53 Survey respondents were recruited through strategic opportunistic and snowball sampling via relevant charitable/third sector organisations including carer groups and support services. Paper recruitment packs were posted to a total of 461 dementia and/or care-focused support groups run by the Alzheimer's Society and the Princess Royal Trust for Carers. These paper packs were followed up a fortnight later with email reminders. Recruitment emails were sent to an additional 13 dementia-related organisations, and recruitment details were posted on four online discussion forums. The questionnaire was live for a period of four months, between February and May 2011. Carers could either complete the questionnaire online (
n = 154) or contact the research team for a postal questionnaire pack (
n = 31).
Given the varied nature of the recruitment strategy and our reliance on the goodwill of ‘gatekeepers’, it is difficult to assess the response rate, although a basic calculation of number of completed questionnaires (185)/number of recruitment messages, emails, and postal contacts (939), suggests a response rate of just under 20% overall. Participants in the focus groups and interviews were predominantly recruited from within the questionnaire responses. As this research is based on an opt-in, convenience sample, there are limited claims that can be made about the generalisability of the findings, although we do note where our findings are similar to those in the previous research. Quantitative results from the survey were analysed using SPSS to find frequencies and differences between groups of respondents. Qualitative results from the focus groups and interviews were independently coded by the research team, using both deductive and inductive codes. Deductive codes were generated from the project research questions, inductive codes presented themselves as patterns within the data.
Table
1 provides outline demographic information for questionnaire respondents, and the people they care for. The majority of respondents were women (
n = 128, 69.2%) caring for roughly equal numbers of men (87, 47%) and women (97, 52.5%). Respondents were overwhelmingly white (97.2%) and heterosexual (97.3%), with a mean age of 62.2 years. A majority identified their religion as Christian (
n = 139, 75.1%). Most carers (
n = 143, 77.3%) reported no disability, although just under a quarter (
n = 42, 22.7%) reported having a disability, including arthritis, cancer, diabetes, and mobility impairment.
Table 1.
Questionnaire demographics
Fifteen participants attended four focus groups held in two large cities and two towns in central and southern England between September and December 2011. A total of 34 people were invited to participate in the focus groups, and originally 18 carers had agreed to participate, but three were not able to attend on the day. The response rate for focus group participation was therefore 44%. All participants were white and heterosexual. In total 8 h 40 min of focus data were collected, with each group lasting around 2 h.
As we can see from Table
2, nine (60%) of the participants were women, six (40%) were men and their mean age was 66 years (range 47–87). The majority (12, 80%) were currently caring and three participants were bereaved. Ten (67%) participants defined as middle class, while five (33%) defined as working class. Ten (67%) were caring for a spouse, while five (33%) were caring for a parent. The mean age of the person the participants cared for was 78.9 years (range 69–92) and they had been diagnosed with a range of dementias: five (33%) with Alzheimer's disease; five (33%) with vascular dementia; two (13%) with Lewy Body dementia; two (13%) with fronto-temporal dementia; and one with mixed Alzheimer's and vascular dementia. About half of the people with dementia resided in their own home and half in a nursing home.
Table 2.
Focus group demographics
Table
3 provides demographic information about carers who were interviewed. Interviews ranged from 1 h 16 min to 2 h 7 min (mean length 1 h 37 min) and were conducted in participants' homes between November 2011 and January 2012. Most interviews were conducted in the Midlands, three were conducted in the North of England and two in the South. All participants were white and all identified as heterosexual apart from one bisexual woman. Eighteen potential interviewees were invited to participate, so the response rate was 61%, although only two carers who were contacted actively declined participation. Interviewees' mean age was 63 years (range 56–79) and the mean age of the person they cared for was 79.5 years (range 60–95).
Table 3.
Interview demographics
B. Statistical Findings: Antipsychotic Medication
In the questionnaire, 52 carers (28.1%) reported that the person with dementia that they care for had been prescribed antipsychotic medication. This proportion roughly corresponds with the proportion of people with dementia prescribed antipsychotics identified by Banerjee in his investigation into the prescription of antipsychotic medication to people with dementia.
54 These 52 carers reported 72 prescriptions of antipsychotic medication, as several (
n = 15, 8.1%) reported the prescription of more than one type of antipsychotic. Table
4 provides a breakdown of the antipsychotic prescriptions. Of the types of antipsychotic medication prescribed, Risperidone, which is the only antipsychotic drug licensed for use with people with dementia, accounted for just 15 (21%) of these reported prescriptions. As such, up to 79% of the prescriptions of antipsychotic medications reported by respondents in this study may be ‘off-label’ prescriptions.
Table 4.
Reported prescriptions of antipsychotic drugs
A series of Chi-Square analyses were run to interrogate factors that may increase the likelihood of a person with dementia being prescribed antipsychotic medication. No significant differences were found in relation to the gender or self-identified social class of either the carer or the person with dementia, nor on whether the carer lived with the person with dementia. Three statistically significant differences were found in these data. First, there was a significant association between the reported diagnosis, and the prescription of antipsychotic medications, with those with a diagnosis of frontotemporal dementia (FTD) (
n = 17, 41.5%) and dementia with Lewy bodies (DLB) (
n = 3, 50%) more likely to report such prescriptions than those with other diagnoses (
x↑2 = 21.313, d
f = 8,
P = 0.006). This difference can be explained, at least in part, by the different sets of symptoms that people with these rarer forms of dementia experience. These forms of dementia often have significant behavioural components, including for FTD behavioural difficulties, and for DLB fluctuating cognitive disturbance.
55 Importantly, however, the use of antipsychotic medication for DLB is explicitly contra-indicated in the NICE guidance, ‘because those with DLB are at particular risk of severe adverse reactions’.
56
The second statistically significant finding was that carers of people with dementia who reported the prescription of antipsychotic medication were significantly more likely (
x↑2 = 10.921, d
f = 1,
P = 0.001) to report having had cause to complain (
n = 31, 65.3%) about the way the person they care for was treated by professionals than those who did not report the prescription of antipsychotic drugs (
n = 49, 37.1%). Finally, and perhaps most interestingly, there was also a significant association between observed and expected frequencies for antipsychotics prescribed to people with dementia living in formal residential or nursing care (
x↑2 = 5.344, d
f = 1,
P = 0.021). Carers of people with dementia living in formal care were therefore statistically significantly more likely to report that the person they care for had been prescribed antipsychotic medication. If we look solely at those people with dementia living in formal care (
n = 39, 22% of total respondents), the proportion of people with dementia prescribed antipsychotic medications increases to nearly one half of these (
n = 17, 43.6%). There are likely to be a number of factors that contribute to this finding, including that BPSD are factors in carer strain,
57 and in the early institutionalisation of people with dementia.
58 These are, however, statistically significant differences, which echo findings from previous research exploring these issues.
59 These statistical findings can be interrogated further by exploring the qualitative data from carers in the questionnaire, focus groups, and interviews.
C. Qualitative Findings: Carers Experiences of Antipsychotic Medication
Alongside these three statistical findings, the qualitative comments highlight three themes in respect of carers' experience of the use of antipsychotic drugs in people with dementia. First, carers document the negative effects on people with dementia from the use of this class of medication. Second, they spoke of their own interventions to reduce or prevent the prescription of antipsychotics to the person they care for, including removing the person with dementia from in-patient or respite care in order to protect them from the prescription of antipsychotic medication. Finally, some respondents spoke of alternatives to antipsychotic medication for the treatment of BPSD.
While only one participant spoke of what would be described in the clinical literature as a severe adverse effect: ‘my husband was so poorly following several near death experiences with antipsychotics’ [Quest_92],60 a variety of other harms were described by these participants. Many participants highlighted the sedative effects of these medications, for example:
My Mother … was given antipsychotic drugs that turned her into a zombie. [Quest_62]
I was strongly against the use of this drug [Seroquel] after it left my dad in a zombie state [Quest_88]
He was, at one point, very much like a zombie because of the antipsychotic drugs he was on because he'd been violent. [FG3_Angela]
They put her on these antipsychotic meds, which I've looked up on the internet and they are- I think they're being withdrawn now. They made her catatonic, basically. [Int5_Sue]
Clearly, carers find the sedative effects of antipsychotic medication distressing and unhelpful. Perhaps more importantly, these carers' experiences highlight that the use of antipsychotic medication as a means of controlling behaviour can be experienced as harmful even in the absence of ‘severe’ side effects. Several carers attributed the prescription of antipsychotics to a lack of knowledge, training, or awareness of the negative effects on people with dementia. Consider this quote from a questionnaire respondent:
I did speak with Dr [name] about the drug he'd prescribed he said it was for my dad's depression (my dad has never suffered from depression) after researching online about this drug I went to my dad's doctor and strongly requested that my dad came off this drug as it had a black box warning and should not be used as it was for Bi-polar disorders - it stated that it should not be given to people over 65 suffering from dementia and heart problems - it was given to my dad as a suppressant- I was angry that this drug was given to my dad in the first place. I think some doctors and nursing staff have very little knowledge if any about caring for dementia people. [Quest_88]
In this excerpt, a woman (55) who provides most of the day-to-day care for her father (78) and for whom she has financial Power of Attorney (PoA)
61 describes an instance of the prescription of Seroquel.
62 She describes her use of the Internet to find out about the medication her father had been prescribed. It is clear from the way that she tells this story that not only had the prescription been ‘off-label’, but also that the possible adverse effects had not been discussed with her, as her father's carer. While it is possible that her father had capacity to consent to this treatment at the relevant time, if he did not have capacity, then the prescriber has a duty to follow the best interests test in the Mental Capacity Act 2005 (MCA). Under the MCA, before a health professional can prescribe medication to a person who lacks the capacity to consent, they must firstly determine that it is in that person's best interests to do so. As part of the best interests’ determination, they must, where ‘practicable and appropriate’ consult with and take into account the views of anyone engaged in caring for the person,
63 or any ‘donee of a lasting power of attorney’.
64 As antipsychotic medication has a sedative effect, it is also important to consider the possibility that such a prescription may amount to restraint,
65 and could be potentially be considered to amount to a deprivation of liberty under Article 5(1) of the European Convention on Human Rights (ECHR) if ‘the health care professionals treating and managing the [patient] exercised complete and effective control over his care and movements.’
66 In cases where there is a possibility of the deprivation of liberty,
67 then the Deprivation of Liberty Safeguards (DOLS)
68 procedures must be followed.
Mick,69 who was interviewed for the Dementia Talking project, also spoke of his experience of looking up symptoms on the Internet:
Well I mean Kate was leaning over to side and one of things they were saying was er, she were constipated. I said ‘She certainly isn't constipated cos I've been there when they changed her pads.’ So I put this leaning into Alzheimer's website and it come up with nothing. Got onto Alzheimer's Association and they call it Pisa Syndrome. They've had it documented for ages. Put it down purely to drugs. So care home, well it were nursing home, that Kate was in at that time, I told GP about drugs, she said ‘Well I shouldn't touch her drugs, but seeing’- they'd just put her on, I forget what it were called, just put her on this drug. [ … ] Anyway the- this doctor rung care home up and said ‘How's she doing?’ She said ‘Oh she's still-’ she were getting a bit agitated again, you know, and er[sic] so they doubled this drug. Well she started leaning more and falling, actually falling. So I told GP, and she said ‘Well I'll cut her back to what she was on on[sic] original dose.’ Well she straightened up in two days, and then it wasn't long they took her off it completely. [Int10_Mick]
Clearly Mick found relevant information online that allowed him to negotiate with the GP, and question the particular prescription that had been given to his wife. He then attributes his intervention to the reduction in dose, lessening of the drug-induced dystonia his wife was suffering from, and subsequent withdrawal of the medication. Several carers in our study described having to intervene when medication that they thought was inappropriate for the person they care for was prescribed:
I was appalled at the use of anti-psychotic drugs (once I realised what they were and after I took my husband off them) in the general hospital given by medical staff who did not seem to realise their effect on someone with dementia. He was up all night and extremely confused and then slept by day once I visited him and enabled him to rest. I stayed up all one night once he was home to document their effect on my husband and then gradually took him off them. They are EVIL! … They make people worse not better and they kept increasing the dose to try and make him more ‘manageable’. They failed. [Quest_119]
Again, in this account from a woman (62) caring for her husband (72), who reported the prescription of two different types of antipsychotic medication (quetiapine and haloperidol), there is another instance of carers clearly not being provided with full information about the off-label prescription of antipsychotic drugs (‘once I realised what they were’). Here, she weaned her husband off the medication once he was home from hospital. For other carers, the prescription of antipsychotic drugs resulted in them removing their family member from formal care provision.
Another occasion he went to a unit for assessment which was totally lacking in dementia care, he was drugged and put in a nappy when he had no continence problems, he fell and sustained a head injury as a result of this so next night he was put on the floor on a mattress. When I visited the staff supposedly caring for him were sitting watching TV while he was wandering up and down in a dazed state and when I removed him the staff became very defensive and I subsequently found that this was not an isolated incident. [Quest_63]
Here, this woman (62), who cared for her husband (now deceased), who was also prescribed quetiapine, describes a significant failure of care, which resulted in her removing him from the assessment unit prematurely. The way she describes his treatment ‘he was drugged and put in a nappy’ suggests that the treatment he received may have been inappropriate, and was unlikely to have been in his best interests. There may even be some possibility of interference with his rights under the inhumane or degrading treatment branch of Article 3 ECHR. Many carers articulated very strong feelings about the inappropriateness of the prescription of antipsychotic medication. In a focus group, Tom70 shared an experience from when his wife had been in respite care while he underwent major surgery:
During the sixth week [of respite] she started having nightmares, and so they wanted to give her antipsychotics, and I said ‘no’. But the doctor actually prescribed them, and I think she was given one tablet and it gave her the runs, and they didn't give her anymore. But as soon as they said that, I- although I wasn't fit enough to bring her home, I brought her home. [FG4_Tom]
Similarly, in an interview, Sue described removing her mother from in-patient care because of the effects of antipsychotic medication:
They made her catatonic, basically, she was- So we took her out … we discharged her and we took her home and she said ‘oh thank God I'm home.’ And she told me all about what had happened in hospital and how she'd had a fall unsupervised, she'd been unsupervised and gone to the toilet and had a fall. And black and blue, they made her sign a disclaimer. She told me about that. We didn't know about that. She said ‘they made me sign a form saying, you know, I'd been offered help and I didn't want’ … something like that. [Int5_Sue]
In all three of these excerpts, the familial carer describes removing the person with dementia from formal care, in an assessment unit, a respite care home and hospital respectively, because they experienced failures of care associated with the prescription of antipsychotic medication. This highlights the ways that the potential harms associated with the use of antipsychotic drugs to control BPSD are not limited to biochemical side effects of the medication (e.g. stroke, death) but also include over-sedation and exacerbation of behavioural problems, which require additional input from carers. Without such additional support, the antipsychotics can lead to the person with dementia experiencing physical injuries, falls, and heightened confusion.
Viv, whose husband has a complex diagnosis of a rarer type of dementia, and who can exhibit ‘very aggressive, challenging behavior’ spoke of her conversation with her husband's neurologist:
The neurologist wants to prescribe, um, antipsychotic drugs, which are now being debated as being-you shouldn't do that, you know. So the last time we went to the neurologist at [the hospital] he said ‘are you using Seroquel?’ I said, ‘well, honestly, doctor, I prefer not to use Seroquel’, I mean it's a real chemical cosh, you know, ah, and it makes him very weird. I mean, he's very weird anyway, but the Seroquel, the chemical cosh makes him, sort of, doubly bad. [FG2_Viv]
This mirrors the findings from previous qualitative research with old age psychiatrists about why they prescribe antipsychotic medication to control BPSD.71 Wood-Mitchell et al. found that ‘psychiatrists often felt pressured to “do something” and believed that in many cases non-pharmacological approaches were not feasible due to a lack of resources, time constraints and difficulties in implementation’.72 This is in contrast to the NICE guidance which suggests that all other approaches to control challenging behaviour should be attempted prior to the prescription of antipsychotics.73Another focus group participant, Angela, spoke of her concerns that her husband would be prescribed antipsychotics again because of his behaviour:
Over the last weekend he's actually hit one of the nurses again. So now, of course they- they don't know why it's suddenly flared up, … he might be in pain, and he can't communicate that and so that may- may be what's making him frustrated and therefore he lashes out. That was waiting for me on Friday when we got home so, you know, it, I- I- I will say I don't want him to go back on the antipsychotic because it made him such a zombie but [sighs] it may be a possibility that we have to face. [FG3_Angela]
Here, it seems that Angela directly links the use of antipsychotic medication to be the possible response to a single incident. She also describes other causes for this challenging behaviour, such as pain and the inability to communicate, or frustration. Just before the above excerpt, Angela said that her husband has been taking memantine,74 which is not an antipsychotic medication but is used to treat dementia, and which has helped to control his challenging behaviour over several months. Similarly, Mick described his experience with memantine:
She were in a care home and they kept calling it violence and I thought it was more agitation than violence … Anyway, we were mentioning it to doctor one time and I said ‘What about this Memantine?’ ‘I don't think it'll work for Kate.’ I said ‘You don't think it'll work or you- you know it won't work?’ He said ‘I don't think it'll work.’ Well deal was that we tried it for three months see how she went on, and it calmed her down. I mean even when doctor came in after three months, even carers were dashing up and telling him she were a lot better, you know, and in fact she's still on Memantine. That would be- she's probably been on Memantine two years. [Int10_Mick]
Memantine is one of the four medications licensed for treatment of the cognitive symptoms of dementia. Memantine is specifically licensed for use in people with moderate to severe Alzheimer's disease, and following the most recent NICE-SCIE Dementia Guideline, can be prescribed for the treatment of cognitive symptoms of moderate to severe Alzheimer's disease,75 and ‘some behavioural effects have been noted.’76 Importantly, therefore, there are other medications that have been proven to help with reducing challenging behaviour in people with dementia. Consider also this excerpt from Tom, during a discussion about antipsychotic medication:
As I say, there must be cases where it's appropriate, but most aren't. And paracetamol, I know a case where it's worked wonders. [FG4_Tom]
Here, Tom is referring to research published by the BMJ in 2011 that found a significant reduction in agitation in people with dementia on a number of measures following an eight-week treatment intervention with analgesics.
77 Findings from research such as this may signal a move away from the use of antipsychotic medication as a first line response to BPSD. Importantly, however, as well as the possibility of prescribing analgesics or memantine to treat BPSD, the increased attention given to antipsychotics may lead to an increase in the prescription other forms of medication, including the off-label prescription of other neuroleptic drugs that also have a sedative effect, and negative side effects.
78
In summary, the qualitative findings from these research projects highlight that carers overwhelmingly report negative experiences of the prescription of antipsychotic medication to people with dementia.
79 In contrast to the severe adverse effects (e.g., stroke, death) of these drugs highlighted in clinical research, carers described a range of other harms experienced by the person with dementia that they care for. They described sedative effects of antipsychotics, leaving people with dementia like ‘zombies’ or ‘catatonic’. Informal carers, including those with power of attorney, reported not being consulted prior to the use of antipsychotic medication nor given any information about the risk/benefit profile of the drugs prescribed. Several carers reported removing people with dementia from formal care settings because of failures of care associated with the prescription of antipsychotics. Finally, some carers spoke of health care professionals' reluctance to prescribe other medication that may help with the behavioural issues that were experienced by the people with dementia that they cared for, in spite of evidence that these alternatives may be effective. All of this qualitative evidence works together with the statistical findings outlined above to provide an overview of carers' experiences of the use of antipsychotic medication in people with dementia. In particular, the experiences recounted by carers provide ample evidence of why carers who had reported the prescription of antipsychotic medication reported higher levels of ‘cause to complain’.
In the next part, we draw together the regulatory framework for off-label prescription, the documented risks of serious adverse effects from the off-label prescription of antipsychotic medication, and carers' experiences of this in practice to explore the legal options for individual redress for harm, and the potential for regulatory reform in respect of off-label prescription. Before exploring the particular legal issues associated with off-label prescribing practices, it is essential to be clear that the flexibility to prescribe medicines off-label is an essential part of medical practice, and our aim in this article is not to argue for this flexibility to be withdrawn from medical professionals. Rather, our argument is that because there is a potentially higher risk of harm to patients from off-label prescription, it should be subject to greater regulatory control, and that there should be redress available where a patient is harmed as a result of off-label prescription.
80
