Polypharmacy and Anticholinergic Burden Scales in Older Adults: A  Longitudinal Cross-Sectional Study Among Psychiatric Outpatients  in a Tertiary Care Hospital

doi:10.21203/rs.3.rs-4612546/v1

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Polypharmacy and Anticholinergic Burden Scales in Older Adults: A Longitudinal Cross-Sectional Study Among Psychiatric Outpatients in a Tertiary Care Hospital

https://doi.org/10.21203/rs.3.rs-4612546/v1

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Introduction

Assessment of pharmacotherapy quality in older adults relies on indicators such as polypharmacy and anticholinergic burden. This study aimed to investigate the correlation between polypharmacy and various anticholinergic burden scales in an elderly patient population.

Methods

This study was conducted at a psychiatry outpatient clinic at AIIMS, Rishikesh, India, from December 2021 to March 2023. Elderly patients (aged ≥ 60 years) who were on at least one psychotropic drug and had a primary working diagnosis of psychiatric illness were included. All psychotropic drugs, including antidepressants, antipsychotics, mood stabilizers, and hypnotics, were evaluated. Anticholinergic burden scales were calculated by the respective tools. Univariate analysis was adopted to determine the factors that may affect polypharmacy.

Results

The study included 1165 elderly patients aged ≥ 60 years. The prevalence of polypharmacy was 20.43%. The most common medications prescribed were clonazepam (61.8%), an anxiolytic; escitalopram (25.52%), an antidepressant; and risperidone (26.14%), an antipsychotic. In terms of hypnotic and sedative medications, 51.92% of the patients were prescribed zolpidem. The strongest association with polypharmacy was observed for the Anticholinergic Load Scale (ALS), with an odds ratio of 4.3 (p < 0.001).

Conclusion

The anticholinergic burden in this cohort of elderly psychiatry patients was high, with 95.1% experiencing a significant burden. Adverse drug events and anticholinergic burden scales were positively associated with polypharmacy, with a stronger correlation between polypharmacy and ALS scores than with other anticholinergic burden scales in older adults.

Anticholinergic Burden

Polypharmacy

Elderly

Psychotropic

Mental disorders are disturbances in a person's cognition, emotional control, or behavior that cause distress or functional impairment in one or more major life domains. Mental disorders, are very common among older adults aged ≥ 60, with an estimated prevalence of 21.4% worldwide according to the Global Burden of Disease Study 2019 results [1].

Cumulative anticholinergic impact resulting from the use of various medications in an individual is termed the anticholinergic burden [2]. Acetylcholine plays an important role in cognitive functions such as learning and memory. Higher cumulative anticholinergic use may be an important risk factor for cognitive impairment [3–4]. Especially in polypharmacy, even drugs with low anticholinergic effects cumulatively may contribute to a significant anticholinergic burden. Several studies have reported association between adverse effects and anticholinergic burden [5–8].

Anticholinergic burden can be assessed in several ways, however, there is ongoing debate about which measurements offer the most precise and therapeutically helpful prognostic information [3]. Anticholinergic risk scales categorize drugs based on their anticholinergic potential and are commonly utilized to assess anticholinergic burden. These scales generally rank the anticholinergic activity of drugs into four categories, ranging from no known anticholinergic activity (= 0) to definite/high anticholinergic activity (= 3) [12–18]. The impact of these variations on accurately estimating anticholinergic burden for a patient is not well understood

The aims of the present study were (i) to determine the impact of several demographic and clinical factors on polypharmacy and (ii) to compare the anticholinergic burden quantified by anticholinergic risk scales.

This was a cross-sectional, prospective longitudinal study at the Psychiatry OPD at the All-India Institute of Medical Sciences (AIIMS), Rishikesh, Uttarakhand, India, from December 29, 2021, to March 2023. Patients were considered for scrutiny based on the following inclusion criteria: (a) were 60 years of age and older, (b) had received at least one psychotropic drug. Consecutive sampling technique used for sample collection.The study’s reporting follows the Strengthening the Reporting of Observational Studies in Epidemiology statement, as shown in a flow chart in Fig. 1.

Ethical considerations

This study was conducted after obtaining due approval from the Institutional Ethics Committee (IEC) (Reference No. 467/IEC/PGM/2021, dated 26/11/2021).

Measures

The main study variable was the use of psychotropic drugs. The prevalence of psychotropic drug use among individuals aged 65 and older was calculated as a percentage of participants referring to the psychotropics included in the Anatomical Therapeutic Chemical Classification System groups. Clinical modification of 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10-CM) a medical classification list by the World Health Organization (WHO) is used for reporting morbidities and comorbidities .Instances of any adverse drug events were recorded in ADR reporting form of the Central Drug Standard Control Organization (CDSCO), Government of India.

Polypharmacy

A numerical definition of polypharmacy is widely used in the literature to facilitate population research and provide a useful construct for clinicians. The most common and most evidence-based definition of polypharmacy is the concurrent use of at least five drugs [9]. In our study, patients were categorized as having polypharmacy or not according to the number of medications that were prescribed at their visit.

Anticholinergic scales

All drugs used by the patients were evaluated with anticholinergic burden scales, and the number of drugs used was recorded. The anticholinergic scales and activity scores assigned to the drugs listed in each scale provides an indication of the potential for adverse outcomes [10]. In our study we made use of seven anticholinergic scales, Anticholinergic Cognitive Burden (ACB) [11], Anticholinergic Risk Scale (ARS) [12], Anticholinergic Drug Scale (ADS) [13], Anticholinergic Load Scale (ALS) [14], Clinician-rated Anticholinergic Scale (CrAS) [15], Anticholinergic Effect on Cognition (AEC) [16], and CRIDECO scale [17].

Statistical analysis

Descriptive statistics were used to describe the demographic and clinical characteristics of the psychiatric older adults. Categorical variables are reported using numbers and percentages, whereas continuous variables are presented using means (M) and standard deviations (SD). Associations between polypharmacy and anticholinergic scale scores were evaluated via univariate analysis. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated, and a p value of < 0.05 was considered to indicate statistical significance. All analyses were performed using SPSS (Version 25; IBM Corporation, Armonk, NY, USA). All figures were graphically depicted using Microsoft Excel Version 2019 (Microsoft Corporation, Redmond, WA, USA).

A total of 1165 patients aged ≥ 60 years were assessed in the study, with 56.74% (n = 661) being men and 43.26% (n = 504) being women. The mean age of the patients was 64.16 (± 5.23) years. Major depressive disorder (22.15%) was the most prevalent disorder, followed by anxiety (18.11%) and mood disorders (14.76%). Schizophrenia and dementia accounted for 9.96% and 7., respectively (Table 1).

Table 1

Demographic, disease and treatment variables (n = 1165)
Variable	Grouping	Frequency	Percentage
Age (years)	60–64	801	68.76
	65–69	190	16.31
	70–74	101	8.67
	75–79	44	3.78
	≥ 80	29	2.49
Mean Age (SD)		64.16	5.23
Sex	Male	661	56.74
	Female	504	43.26
Diagnosis	Major depressive disorder	258	22.15
	Anxiety	211	18.11
	Mood disorder	172	14.76
	Schizophrenia	116	9.96
	Dementia	83	7.12
	Substance use disorder	29	2.49
	Obsessive-compulsive disorder	20	1.72
	Stress and adjustment disorders	11	0.94
	Intellectual disabilities	1	0.09
	Other disorders	264	22.66
Comorbidities	Diabetes	172	14.76
	Hypertension	413	35.45
	Hypothyroidism	70	6.01
	Hyperthyroidism	4	0.34
	Cardiovascular diseases	36	3.09
	Cerebrovascular disease	15	1.29
	COPD	17	1.46
Number of drugs	Average N (SD)	3.16	1.92
	Polypharmacy (5–12)	238	20.43
	No polypharmacy (1–4)	927	79.57
	1	209	17.94
	2	317	27.21
	3	232	19.91
	4	169	14.51
	5	111	9.53
	6	62	5.32
	7	25	2.15
	8	20	1.72
	9	8	0.69
	10	4	0.34
	11	6	0.52
	12	1	0.09
	16	1	0.09
Number of CNS-active drugs	Average N (SD)	1.88	0.95
	1	480	41.20
	2	443	38.03
	3	164	14.08
	4	59	5.06
	5	17	1.46
	6	1	0.09
	7	1	0.09
SD Standard Deviation, CNS Central Nervous System

Moreover, the average number of medications taken daily was 3.16 (± 1.92) per older adult. Polypharmacy was identified in 20.43% of the patients, with 238 patients (20.43%) taking five or more medications concurrently. The average number of CNS-active drugs per prescription was 1.88 (± 0.95), and 58.81% of the patients received more than one CNS-active drug (Table 1).

Clonazepam, escitalopram, metformin, sertraline, mirtazapine, and lorazepam made up half of the prescriptions for anticholinergic drugs, each having a score of ≥ 1 on at least one of the seven anticholinergic scales utilized. (Table 2).

Table 2

Top 10 drugs with anticholinergic properties (anticholinergic score ranging from 1–3)
Drugs with score of ≥ 1 in any of the 7 scales	N (%)	Mean	Median
Clonazepam	364 (17.28)	1	1
Escitalopram	197 (9.35)	1	1
Metformin	165 (7.83)	1	1
Sertraline	141 (6.69)	1	1
Mirtazapine	129 (6.12)	1.3	1
Lorazepam	110 (5.22)	1	1
Risperidone	109 (5.17)	1.2	1
Quetiapine	100 (4.75)	2.2	2
Olanzapine	88 (4.18)	1.8	2
Fluoxetine	70 (3.32)	1	1

The scores of the anticholinergic burden scales in poly-medicated patients and non-poly-medicated patients are displayed in Table 3.. The ALS score had the highest odds ratio (4.30) and a highly significant p value of less than 0.001. Each unit increase in the ALS score increased the risk of polypharmacy by 4.30 times. The CRIDECO and ACB scores showed a moderate relationship with polypharmacy (with ORs of 3.55 and 3.22, respectively). However, the ADS score did not exhibit a statistically significant association with polypharmacy (OR: 1.14; p value 0.43), suggesting a weak relationship (Fig. 2)(Table 4).

Table 3

The scores of the anticholinergic burden scales
Scale	Polypharmacy Mean ± SD	No Polypharmacy Mean ± SD
ACB score	3.6 ± 2.12	2.21 ± 1.55
ARS score	1.4 ± 1.52	1.06 ± 1.3
CRIDECO (CALS)	3.4 ± 1.9	2.06 ± 1.33
ADS score	1.58 ± 1.54	1.17 ± 1.12
AEC score	1.55 ± 1.54	1.14 ± 1.32
ALS score	1.78 ± 1.24	1.04 ± 1.07
CrAS score	1.55 ± 1.62	0.95 ± 1.16
ACB Anticholinergic Cognitive Burden, ARS: Anticholinergic Risk Scale, ADS Anticholinergic Drug Scale, ALS: Anticholinergic Load Scale, CrAS Clinician-rated Anticholinergic Scale, AEC Anticholinergic Effect on Cognition, CALS CRIDECO Anticholinergic Load Scale, SD Standard Deviation

Table 4

The relationship between anticholinergic burden scales and polypharmacy
Factors	Odds ratio	Confidence interval	p value
Female	0.90	0.67–1.20	0.48
ADR^*	1.81	1.27–2.56	< 0.005
Presence of Antipsychotic^*	1.64	1.22–2.21	< 0.005
ACB score^*	3.22	1.28–8.12	0.01
ARS score^*	1.42	1.07–1.89	0.02
CRIDECO (CALS) ^*	3.55	1.27–9.90	0.02
ADS score	1.14	0.83–1.57	0.43
AEC score^*	1.38	1.03–1.86	0.03
ALS score^*	4.30	2.84–6.53	< 0.001
CrAS score^*	1.70	1.26–2.28	< 0.005
ACB Anticholinergic Cognitive Burden, ARS: Anticholinergic Risk Scale, ADS Anticholinergic Drug Scale, ALS: Anticholinergic Load Scale, CrAS Clinician-rated Anticholinergic Scale, AEC Anticholinergic Effect on Cognition, CALS CRIDECO Anticholinergic Load Scale
^* p < 0.05

The term "psychotropic medication" encompasses a broad range of medications that affect mental functioning, behavior, and subjective experiences [18]. Our study revealed a relatively high rate of psychotropic drug prescriptions among elderly patients receiving psychiatric care, with an average of 1.88 psychotropic drugs per patient. Antidepressants were the preferred choice across all diagnostic categories, except for patients diagnosed with psychosis, schizophrenia, and dementia. Notably, benzodiazepine prescriptions were prevalent in our population. These findings align with previous pharmaco-epidemiological studies on psychotropic drug use [19–21].

As a geriatric syndrome, polypharmacy is prevalent in elderly individuals and is closely related to falls, mood disorders, and cognitive and functional decline [22–24]. Similarly, the anticholinergic burden puts older patients at an increased risk of negative clinical outcomes such as falls, delirium, hospitalization, functional decline, and a negative impact on cognitive functions [25–27]. Anticholinergic burden and polypharmacy lead to adverse outcomes and functional limitations in older adults, and these two concepts are often closely related.

The prevalence of polypharmacy reportedly ranges from 20–40% [28]. In our study, the prevalence of polypharmacy was 20.43%. The prevalence of polypharmacy among individuals aged 65 and above has been reported to range from 7–45%, which is significantly greater than that of other age groups [29]. The higher prevalence of polypharmacy observed in most studies might be attributed to the inclusion of individuals aged over 65 years as seniors. In fact, for patients aged older than 65 years or older, the prevalence of polypharmacy was 32.14% in our study.

The prevalence of polypharmacy has risen in recent years, especially among older adults. This increase can be attributed to factors such as increased life expectancy, the presence of chronic diseases necessitating long-term treatment, increased utilization of healthcare services, and the development of new medications.

To the best of our knowledge, very few studies have investigated the relationship between polypharmacy and anticholinergic burden scales. We believe that clarifying the relationship between polypharmacy and anticholinergic burden, both of which are related to the health status of older adults, will provide future researchers with a better view on the factors affecting the functionality of older adults exposed to polypharmacy and/or anticholinergic burden.

In the present study, 95.1% (n = 1108) of the patients were prescribed at least one drug with a score ≥ 1 on any of the seven scales used. According to the univariate analysis, ALS (OR of 4.3) had the strongest relationship with polypharmacy, although the CRIDECO and ACB scales identified more anticholinergic drugs in our study population (61 and 55, respectively), whereas the ALS scale was able to identify only 22 drugs. The observed disparities in the odds ratios might be because the CRIDECO and ACB scales identified anticholinergic drugs even in non-poly-medicated patients (Table 3).

The CRIDECO and ACB scores showed a moderate relationship with polypharmacy (with ORs of 3.55 and 3.22, respectively). ARS, AEC, and CrAS showed a weaker relationship with polypharmacy (OR range from 1.38 to 1.7), whereas the weakest relationship was found for ADS. We may have achieved these results because there are different drugs included in each anticholinergic scale. The number of common drugs in the scales has been reported to be 29 (ADS, ARS, and ACB) [30].

Nortriptyline and chlorpromazine had maximum anticholinergic burden scores (= 3) on all the scales except the ALS scale, which did not include these drugs on the list. The ABC list identified 16 drugs with maximum anticholinergic activity, followed by CRIDECO with 14. These selective discrepancies might have attributed to varied associations with polypharmacy.

According to several studies, a cumulative anticholinergic burden ≥ 3 will increase the risk of falls, cognitive impairments, delirium, and dementia [6]. Unfortunately, 42.23% of the patients in our study had scores ≥ 3 on at least one of the scales.

Apart from the effects on physical and cognitive function, anticholinergic medication use in elderly individuals has recently been demonstrated to affect other disease states, increase the risk of dental caries [7], increase the risk of serious cardiovascular events [8] and cause community-acquired pneumonia [9]. These previously unrecognized associations could significantly impact the medical and medication management of older adults.

Current anticholinergic risk scales tend to oversimplify the complexity of pharmacological mechanisms, which poses significant challenges in geriatric risk assessment due to increased biological variations among older populations. This simplification can lead to an underestimation or overestimation of the risks associated with anticholinergic medications. Given the growing evidence of negative consequences of anticholinergic medications in older adults, deprescribing anticholinergics may be considered part of comprehensive medication management for older adults.

Strengths and limitations

The large sample size and the use of 7 anticholinergic burden scales are strengths of the present study. To the best of our knowledge, very few studies have investigated the relationship between polypharmacy and anticholinergic burden assessed by different scales; however, there are still some limitations. These include the single-center design and observational nature of this study.

The current study demonstrated that polypharmacy and anticholinergic burden scales were more closely related. Although polypharmacy and anticholinergic burden are distinct concepts, they are interconnected. More research is needed to determine which of these two factors has a greater impact on the functionality and health status of older adults, enhancing our understanding of these concepts

Statement of Ethics

Ethical approval and consent to participate in the study protocol were obtained from the Institutional Ethics Committee (IEC) (Reference No. 467/IEC/PGM/2021, dated 26/11/2021), AIIMS, Rishikesh. After the study was explained, written informed consent was obtained from all the participants before the study began.

Conflict of Interest Statement

The authors have no conflicts of interest to declare.

Funding Sources

This study received invaluable sponsorship from Indian Council of Medical Research (ICMR) under Grant No. 3/2/June 2021/PG-Thesis-HRD.

Author Contributions

MB: conception and design, acquisition of data, performed statistical analysis and interpretation of data, drafting of the manuscript. BD: conception and design, review and substantial edits to the manuscript. VR: curated data, reviewed and edited the final draft. HS and AA: revision of manuscript.

Data Availability Statement

The data in this study are available upon written request to the corresponding author.

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No competing interests reported.

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You are reading this latest preprint version

Polypharmacy and Anticholinergic Burden Scales in Older Adults: A Longitudinal Cross-Sectional Study Among Psychiatric Outpatients in a Tertiary Care Hospital

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Abstract

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Introduction

Methods

Ethical considerations

Measures

Polypharmacy

Anticholinergic scales

Statistical analysis

Results

Discussion

Strengths and limitations

Conclusions

Declarations

References

Additional Declarations

Supplementary Files

Status:

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