As per Alzheimer’s Disease International, there is one new person with dementia every three seconds somewhere in the world. Dementia in India 2020 estimates more than 5 million people with dementia in India. Guidelines across the world[3-5] recommend medications to mitigate cognitive and noncognitive symptoms. Recognised pharmacological interventions for cognitive symptoms are acetylcholine esterase inhibitors (AChEI) (donepezil, rivastigmine, and galantamine), N-methyl-D-aspartate (NMDA) receptor antagonist- memantine, and a combination of one of the AChEI and memantine.
Most patients receive clinical attention only when caregivers find behavioural and psychological symptoms associated with dementia (BPSD) challenging to manage. Although medications are not curative, they are effective in temporarily managing selected patients. Psychological and behavioural interventions effectively address BPSD to a certain extent but are not readily available in Indian settings. Commonly prescribed medications for noncognitive symptoms, also termed BPSD associated with dementia, include psychotropic drugs, especially antipsychotics. In some of the patients, antidepressants, mood stabilizers, sedatives, and hypnotics are also prescribed. Antipsychotic medications prescribed to manage the BPSD are associated with side effects like sedation, falls, and stroke and a warning of increased mortality associated with use of atypical antipsychotics in dementia has been issued. However, several patients with dementia would need medications, with appropriate monitoring, when nonpharmacological interventions fail or are unavailable and when there is a high level of distress and risk due to dangerous behaviours.
Prescribing practices in dementia are expected to be based partly on international and national guidelines and partly on prescriber’s knowledge, experience, and treatment preferences. In developing country settings like India, often a single psychiatrist manages a large number of patients without any monitoring mechanisms or audit cycles. Medications for dementia are unique in various ways. Often it is hard quantifying the benefits of the treatment in a progressive neurodegenerative condition. When done, the assessments may be considered subjective. National clinical audits aim to promote quality improvement in patient outcomes but such audits are not common in India. Evaluating current practice is the key to a clinical audit cycle. Clinical audit is a quality improvement process and is cyclical. It aims to assess, evaluate, and improve patient care systematically. In a clinical audit, existing clinical practice is reviewed against explicit criteria and changes are implemented wherever necessary at an individual, team, or service level and further monitoring is used to confirm improvement in healthcare delivery measuring care against criteria, taking action to improve care, and monitoring. A culture of clinical audits at various levels will help in promoting evidence-based practice and promotes rational prescribing practices.
There is a need to understand existing practices at a national level across various care settings, which will form the basis for good practice models to initiate changes at an individual clinician level and at an organisational level. Understanding prescribing practices would also help determine national policies and programs like the National Mental Health Programme or the National Programme for the Health Care of the Elderly and determine training requirements for manpower development. There are only few studies from India assessing the prescribing patterns for dementia that are limited to one center with small sample sizes.[10,11]
Comprehensive analysis of current prescribing practices across different centers and settings is necessary to make and suggest any further changes. A significant positive change in the quality of prescription has been associated with changes in national policies and clinical guidelines. This information is necessary to initiate possible changes in treatment provision which subsequently will improve dementia care. In this background, this study aimed to assess the diagnostic patterns and prescribing practices of psychiatrists for patients with dementia in India.
MATERIALS AND METHODS
Thirty five potential centers from five zones of Indian Psychiatric Society (IPS) were contacted by email/personal social media messaging service inviting to participate in the study. Messages of invitation were also posted in closed social media groups for psychiatrists. Ethical approval from the IPS Ethical Review Board as well as Institutional Ethics Committee approval of the participating centers wherever required were obtained. A retrospective case file study was conducted across various centers in India looking at the sociodemographic and clinical profile of patients with dementia and details of the treatment they received. A semi-structured data sheet specifically designed for the purpose of this study was used to record the information. Data collection was done between September 2020 and March 2021. Assessments were completed by the individual clinicians based on the standard operating procedures followed in their centers, whenever available. Clinical records of patients with a diagnosis of dementia attending the outpatient department or admitted to inpatient wards during the study period and a 12-month period prior to the date of data collection were used. Diagnosis of dementia and subtypes was made by individual clinicians in the participating centers using International Classification of Diseases-10, Diagnostic and Statistical Manual-IV, or Diagnostic and Statistical Manual-5 criteria. A variety of methods including Addenbrooke’s Cognitive Examination scores and Clinical Dementia Rating scores were used to assess the severity of cognitive impairment. Physical comorbidities were documented as reported by the patients and caregivers and no structured instruments were used. All participating centers had case files or electronic records accessible to clinicians but some did not have the prescription details updated in them. Prescription details were gathered either from the case files, electronic records, or the prescriptions given to the patients. Most recent prescription details were gathered if multiple prescriptions were issued. The clinicians documented the psychosocial interventions received by the patients.
Statistical analysis was done using SPSS statistics for Windows version 22. Means and standard deviations were calculated for continuous variables. Categorical variables were described using frequency and percentage.
Prescriptions of patients with dementia
Sixteen centres expressed their willingness to participate and contributed data to this multicenter study. Ten (62.5%) centers were from the government sector and 6 (37.5%) centers were from the nongovernmental sector. Similarly, ten of them were teaching institutions and six were nonteaching centers. Information from the case records of 586 patients was obtained from these centers across India. Most number of case records were from centers in IPS South zone 202 (34.5%) followed by the East zone (n = 146; 24.9%). The number of case record from other zones were North 102 (17.4%), West 88 (15%), and Central 48 (8.2%). Data of about two-third (n = 376; 64.2%) of the patients were from government centers. Four hundred and three (68.8%) patient records were from teaching centers.
The mean age of the patients was 71.14 years (SD = 9.42), ranging from 45 to 103 years. There was a slight male preponderance (54.8%) in the sample. Majority (89.9%) were outpatients and most of them (45.6%) were from urban areas. Majority of the participants were married (74.7%) and 53.7% were from middle socioeconomic status. Most patients (73.4%) had no medical reimbursement options [Table 1].
Past psychiatric diagnosis
Among the study sample, 50 (8.5%) patients had a psychiatric diagnosis from the past; 22 (3.8%) had depression. A small number of patients had other psychiatric disorders Table 1.
Dementia subtypes, severity, and BPSD
Commonest dementia subtype among this patient group was Alzheimer’s disease (AD) (n = 349; 59.6%) followed by vascular dementia (VaD) (n = 117; 20%). About one-fourth (n = 152, 25.9%) of the patients had a mild degree of dementia, 316 (53.9%) had moderate degree, and 118 (20.1%) had severe degree [Table 1]. Details of the prevalence of dementia subtypes and degree of severity are given in Table 1. BPSD was present in 472 (80.5%) patients.
Three hundred fifty five (60.6%) patients with dementia had medical conditions for which 47.4% of them were taking medications. Overall, 261 (44.5%) patients had cardiovascular disorders and 149 (25.4%) had diabetes mellitus. Among patients with AD, 53.3% had physical problems. Three-fourth (n = 90; 76.9%) patients with VaD had physical disorders. Among those with VaD, 81 (69.2%) patients had cardiovascular problems, 39 (33.3%) had neurological problems, 41 (35%) had diabetes, and 71 (60.7%) were taking medications for them [Table 2].
Among 586 patients, 524 (89.4%) were on medications for dementia (donepezil, rivastigmine, galantamine, and memantine). About two-third (n = 380; 64.8%) were on antipsychotics [Table 3].
Medications for dementia
Donepezil (n = 230; 39.2%) was most frequently prescribed medication for dementia, closely followed by donepezil-memantine combination (n = 225; 38.4%). Memantine without any AChEI was prescribed for 58 (9.9%) and other AChEI medications for 11 patients (1.9%).
Three hundred twenty one (92%) patients with AD and 109 (93.2%) patients with VaD were on medications for dementia. Among patients with AD, most common prescription was for donepezil-memantine combination (n = 157; 45%) and 139 (39.8%) patients were on donepezil only. Among patients with VaD, 57 (48.7%) were on donepezil and 39 (33.3%) on donepezil-memantine combination. More than half (n = 54; 55.7%) patients with mild AD, about one-third (n = 65; 37.8%) with moderate AD, and one-fourth (n = 20;25%) with severe AD were on donepezil while these figures were 51.9%, 50.7%, and 35.3% for VaD. Mean dose of donepezil was 8.69 mg/day (SD = 4.62 mg/day), median dose 10 mg/day, while the most commonly prescribed dose was 5 mg/day (n = 209; 60.1%). For memantine, the mean dose was 12 mg/day (SD = 6.08 mg/day) while the median and the commonest (n = 90; 41.3%) dose prescribed was 10 mg/day.
Almost two-thirds of the study population (n = 380; 64.8%) patients were on antipsychotics [Table 3]. Quetiapine (n = 213, 36.3%) was the most frequently used antipsychotic followed by risperidone (73, 12.5%). A small proportion (n = 31; 5.3%) were on two antipsychotics simultaneously; the most common combination was quetiapine and risperidone (n = 12; 2.1%) followed by olanzapine-risperidone (n = 4; 0.7%). Two (0.3%) patients each received Aripiprazole-Haloperidol, Clozapine- Quetiapine, Clozapine-tiapride, Olanzapine-Quetpine, and Quetiapine-Tiapride. One patient each received Amisulpiride-risperidone, Aripiprazole-olanzapine, Blonanserin-tiapride, haloperidol-quetiapine, and Risperidone-trifluoperazine. Mean dose of quetiapine prescribed was 76.08 mg/day (SD = 79.59 mg/day), median dose 50 mg/day, and the most commonly dose prescribed 25 mg (N = 36; 28.3%). For risperidone, the mean dose was 1.79 mg/day (SD = 1.3 mg/day) while the median and the most common (N = 14; 35%) prescribed dose was 1 mg/day.
Overall, 113 (19.3%) patients were on antidepressants and the most common medication prescribed was escitalopram (n = 50; 8.5%). Three patients (0.5%) were on two antidepressants each. Among 80 (13.7%) patients who were prescribed sedatives/hypnotics, 34 (5.8%) were on clonazepam and 21 (3.6%) on melatonin. Two (0.3%) of them were on 2 medications each. Mood stabilizers were prescribed for 16 (2.7%) patients among whom 10 (1.7%) were on sodium valproate/divalproex sodium [Table 4].
One hundred seventy two (29.4%) patients were on supplements, vitamins, neurotrophic, or nootropic agents. Most commonly used were vitamin B supplements (n = 76; 13%). Others include multivitamins (n = 57; 9.7%), vitamin D (n = 18; 3%), piracetam (n = 16; 2.7%), and cerebroprotein hydrosylate (n = 11; 1.9%). A few patients were on acetyl- l –carnitine, citicoline, etc.
To capture the entire breadth of treatment approaches clinicians use in real-world settings and not limit to a certain set of interventions, in this survey the clinician responded yes/no, to the question whether the patients and caregivers were receiving any psychosocial interventions. Subsequently, they documented the interventions received. Three hundred nineteen (55.4%) patients were receiving psychosocial interventions and 221 (38.4%) not receiving any. Caregivers of 374 (65%) patients were receiving psychosocial interventions, while 169 (29.3%) were not receiving any. This information was not available for 36 (6.3%) patients and 33 (5.7%) caregivers.
This study provides an insight into the everyday practice of diagnosing and treating dementia among psychiatrists in India. This is the first multicenter study to assess the prescription patterns for dementia in India to the best of our knowledge.
Information from the case records of 586 patients were obtained from centers from all five zones of IPS. There was representation across government and non-governmental centers. Majority (64.2%) of the patients were from centers in the government sector and training centers (68.8%). There was a slight male preponderance of the patient group which had a mean age of 71.14 years. Majority were outpatients, married, from middle socioeconomic status, and had no medical reimbursement options. The commonest dementia subtype was AD followed by VaD. Around 60% had a physical comorbidity. Majority (89.4%) were on medications for dementia and the most frequently prescribed treatment was donepezil (39.2%) followed by donepezil-memantine combination (38.4%). In this survey, 64.8% patients were on antipsychotics, 19.3% patients were on antidepressants, and 13.7% patients were on sedatives/hypnotics. 55.4% of patients and caregivers of 65% of patients were receiving psychosocial interventions.
The frequency of dementia subtype diagnosis reflects its prevalence in the hospital attending population and possibly in the community. There are wide variations in how dementia subtyping is done in clinical practice. While a detailed clinical examination, neuropsychological testing and imaging investigations help in a more accurate subtyping; such facilities are not available in most centers. While acknowledging the borders between different subtypes of dementia are by no means distinct, it was estimated that world-wide, the most common subtype of dementia is AD (50% to 75%) followed by VaD (20% to 30%). FTD accounts for 5% to 10% of the subtypes. The commonest subtype of dementia reported from a clinic-based study from western India was AD (65.6%) followed by VaD (21.6%). FTD accounted for 10.4% of the prevalence and LBD 2.4%, the figures comparable to the findings of the present study. In a clinic-based study from south India, AD was the most common subtype of dementia (38.3%) but the prevalence much lesser than in the present study. VaD was present among 25.4% of their study population followed by mixed dementia in 8.6% and FTD in 18.7% of the patients. Similar prevalence rates of the common subtypes were found in a weekly dementia clinic in a medical college setting as well. A clinic-based study of a north Indian population also showed similar prevalence rates. AD accounted for 30% followed by VaD in 26%, mixed dementia in 21%, Parkinson-related dementia in 11%, and FTD in 7% of the study sample. History of depression which is considered to be a risk factor for dementia was low (3.8%) in the present study which could be due to the nature of the study, which is based on clinical records. Presence of BPSD is distressing and increases the burden of care. In this study, a high prevalence (80.5%) was reported similar to a large Indian study.
Physical comorbidity and its treatment
There is a significant association between dementia and various medical comorbidities including cardiovascular and neurological conditions; two most frequent comorbidities being hypertension and diabetes. These comorbidities increase healthcare costs and mortality rates. We found prevalence of physical disorders to be 60.6%, similar to that reported by another Indian study. Comorbid medical conditions like type 2 diabetes which had a prevalence rate of 25.4% in this study are reported to accelerate cognitive decline in the elderly.[21,22]
Medications for dementia
Efficacy of AChEI, memantine, and combination therapy of memantine plus donepezil have been established in treatment of patients with dementia. NICE guidelines recommend that all three AChE inhibitors, donepezil, galantamine, and rivastigmine, can be used as monotherapies in mild to moderate AD. Memantine can be used in moderate AD for people who are intolerant of or have a contraindication to AChE inhibitors or severe AD. Memantine in combination with AChEI can also be considered in moderate to severe AD. IPS clinical practice guidelines for management of dementia follow similar principles of treatment. Among patients with AD, the most favoured (45%) medication for dementia treatment in this sample was donepezil-memantine combination, followed by donepezil (39.8%). Among those with VaD, 48.7% were on donepezil and 33.3% on donepezil-memantine combination. AChE inhibitors or memantine may be considered for people with VaD if they have suspected comorbid AD, Parkinson’s disease dementia, or DLB. Use of memantine is recommended for people who have dementia with Lewy bodies if AChE inhibitors are not tolerated or are contraindicated.[3,4] In our survey, we found that among patients with LBD, 40% were on donepezil and 25% on donepezil-memantine combination.
Prescription rates of drugs for dementia vary widely across countries and dementia subtypes ranging from 25% to 90%.[26-30] In this study, majority (89.4%) of the patients were on medications for dementia and overall, the most frequently prescribed antidementia treatment was donepezil similar to other Indian studies with comparable doses[10,11] closely followed by donepezil-memantine combination (42.9%).
Antipsychotics are generally recommended only for people who are either at risk of harming themselves or others or experiencing agitation, hallucinations, or delusions that are causing them severe distress. In people with DLB or Parkinson’s disease dementia, antipsychotics can worsen the motor features of the condition and may cause severe antipsychotic sensitivity reactions. Low-dose atypical antipsychotics can be considered for severe agitation, aggression, and psychotic symptoms.
In a large meta-analysis of 43 studies, the pooled prevalence of any antipsychotic use among patients with dementia was 27.5% varying from 12.3% in community settings compared with 37.5% in long-term care settings. Use of psychotropic medications especially antipsychotic medications to manage BPSD is a widely practiced strategy with risks of over prescription and also failing to stop the medications even when they are no longer clinically indicated. With reports of increased mortality risk associated with the use of typical and atypical antipsychotics in dementia, there has been an increased focus on measures to reduce this practice. Antipsychotic medications are often used to manage BPSD which have significant but small benefits which have to be balanced against faster cognitive decline, increased risk of mortality, and cerebrovascular events and death. With the European Medicines Agency approval of risperidone as the only antipsychotic for the short-term treatment of persistent aggression in patients with moderate to severe AD who are not responsive to nonpharmacological interventions and who pose a risk of harm to self or others, several clinical guidelines support its use.
In our survey, 64.8% patients were on antipsychotics, with quetiapine (36.3%) being the most frequently used antipsychotic followed by risperidone (12.5%). This rate was comparable with other studies from India. In a tertiary referral center, 53% received antipsychotics and the commonest agent used was quetiapine. In another Indian study, around 62% were prescribed antipsychotic drugs and the commonest was quetiapine (38.46%). High antipsychotic prescription rates could be indicative of the complexity of clinical features patients present with, seeking psychiatric consultations after the onset of significant BPSD, large number of patients attending the hospitals when compared with the available resources to provide nonpharmacological interventions and poor support in the community. When using antipsychotics, the recommendations are to use the lowest effective dose for the shortest possible time, to reassess the person at least every six weeks, to check whether they still need medication and to stop antipsychotics if the person is not getting a clear ongoing benefit from taking them. IPS guidelines suggest considering antipsychotic medications only if symptoms are persistent or when there is an imminent risk of harm to the person or carer.
When the prescriptions were reviewed, 17.9% patients were on antidepressants. Antidepressants are found to be helpful in BPSD to some extent. There is paucity of research to make any useful conclusions on the use of antidepressants for BPSD in dementia. Restricting antidepressant use to those with pre-existing severe mental health problem has been suggested. Overall, 2.4% patients were on mood stabilizers. IPS guidelines acknowledge mood stabilizers may be useful in the management of agitation (IPS). Overall, 13.7% patients were on sedatives/hypnotics. These medications increase the risk of deterioration of cognitive functions, sedation, paradoxical disinhibition, risk of falls, and fracture of the femoral neck and risks related to benzodiazepine use are high among the elderly. When absolutely necessary drugs with a shorter duration of action may be used.
Among the patients in this study, 172 (29.4%) were on supplements, vitamins, neurotrophic, or nootropic agents. Most commonly used were vitamin B supplements (n = 76; 13%). High rates of prescribing folic acid and vitamin B12 but without performing adequate tests were reported elsewhere. Vitamin deficiencies as a cause for reversible dementias have been reported in India[39-41] and probably is a modifiable contributor to cognitive impairment.
55.4% of patients were receiving some sort of psychosocial interventions/support. Psychosocial interventions reported include structured activity scheduling, behavioural management, cognitive retraining, cognitive stimulation, supportive therapy, and reminiscence therapy. Caregivers of 65% patients were receiving psychosocial interventions. The interventions include psychoeducation, group therapy, caregiver training, counselling, memory clinic inputs, supportive therapy, virtual interventions, counselling, help with handling caregiver stress, etc. An extensive review of nonpharmacological interventions to treat BPSD classified them into sensory stimulation interventions, cognitive/emotion-oriented interventions, behaviour management techniques (for the person with dementia, the caregiver or the staff), multicomponent interventions, and other interventions, such as exercise and animal-assisted therapies. The most promising treatments appeared to be music therapy and some behavioural management techniques, particularly those involving caregiver-oriented and staff-oriented interventions. For behavioural and psychological symptoms associated with dementia, IPS guidelines suggest using nonpharmacological interventions as first line for all. Psychosocial interventions based on World Health Organization, Mental Health Gap Action Programme (mhGAP) focuses on psychoeducation, management of BPSD, promoting activities of daily living and community life, interventions to improve cognitive functioning, and offering support to caregivers.
This study collated the diagnostic patterns and prescribing practices of psychiatrists for patients with dementia in a naturalistic setting. These data would be essential before a full-fledged audit could be performed. This information on real-world practice might also help generate standards specific to Indian context and promote discussion to maintain and promote high quality clinical care. In a country like India, where there is wide variation and diversity in clinical practice settings, forming country-specific standards is a challenging task. In addition to clinical guidelines, current clinical practice should also be taken into account while choosing standards to be compared against in clinical audits. The findings from this study would contribute toward this purpose and generate discussion among professionals about what contributes evidence-based but pragmatic minimum standards of care in Indian settings.
The study’s retrospective nature makes the findings limited in its generalizability; prospective studies with larger sample sizes would be more helpful in this regard. As the study period overlapped with the pandemic of COVID-19, there were restrictions in accessing medical records from several centers. The pandemic may also have kept several elderly away from hospitals for consultations and follow-ups and some may have used tele-psychiatry facilities. The data were gathered only from 16 centers and future studies should focus on collating prescriptions from more centers and representative of more prescribers. We did not gather information regarding the use of any objective criteria to assess the severity of dementia or BPSD and there would be variability in how these assessments were done among clinicians. Lack of full and appropriate documentation is a challenge faced by many centers which has reflected in the incompleteness of some data accessible for the study.
Diagnostic and prescription patterns in dementia that emerged from this study are comparable to other studies nationally and internationally. Overview of prescription patterns seemingly follow the basic principles as suggested by the IPS clinical practice guidelines. Comparing current practices at an individual and national level against accepted guidelines, obtaining feedback, identifying gaps, and instituting remedial measures help to improve the standard of care provided. Such audit cycles should be an essential part of clinical practice.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
This study was supported by a grant from Indian Psychiatric Society under the aegis of Research, Education, and Training Foundation Subcommittee.
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