1. INTRODUCTION
Geriatric patients often require extra care due to several risk factors [1]. Concomitant illnesses are preeminent in the older people for a variety of reasons, like age-related alterations and inheritable traits [2]. Due to multiple co-morbidities, these geriatric patients are using multiple prescription drugs or polypharmacy [3]. In the elderly population, 90% population take multiple medications (two or more drugs), only 37% elderly population meet the strict definition of polypharmacy (≥5 medications) [4].
Polypharmacy in geriatric patients is difficult to handle and leads to non-treatment compliance due to overuse, abuse, missing drug doses, and drug schedules [5]. The estimates of non-treatment compliance among the elderly range from 40% to 75% [6]. Non-treatment compliance is especially critical in geriatric patients, who are more vulnerable than younger patients to suffer negative consequences. It leads to reduced treatment effectiveness, greater likelihood of complications, adverse drug events, altered treatment plans, increased healthcare costs, poor outcomes, and reduced quality of life [7,8]. According to a WHO (World Health Organization) assessment, 50% of chronic disease patients do not take their prescriptions exactly as prescribed [9]. Non-treatment compliance is allied to side effects, lack of knowledge, poor efficiency, financial difficulties, lack of caregivers, distance to hospital, lack of time, and most importantly, anti-cholinergic drugs [10–14].
The treatment with anti-cholinergic drugs and other drugs that have anti-cholinergic activity is frequently used in geriatric patients. Anticholinergic medicines inhibit the neurotransmitter acetylcholine, which is involved in critical body functions such as muscle contraction, digestion, and memory [15]. Cumulative anti-cholinergic effects, known as anti-cholinergic burden, are attributed to significant peripheral and central adverse effects like dry mouth, constipation, impaired vision, tachycardia, urine retention, dizziness, delirium, falls, dementia, and even cognitive impairment [16–18]. Clinical observations suggest that continued use of anti-cholinergic could lead to a greater risk of side effects due to a diminished number of cholinergic neurons. Various tools have been developed to measure the anticholinergic burden and predict the likelihood of negative anticholinergic consequences, including the anti-cholinergic cognitive burden scale (ACB), (anti-cholinergic risk scale), (anti-cholinergic drug scale), and (anti-cholinergic activity scale). The most commonly used scale for measuring anticholinergic load is the Anticholinergic Cognitive Burden Scale.
However, limited evidence is available in the Indian clinical practice setting despite the high prevalence of polypharmacy among the older population. Further, there is limited research that has focused on a direct relationship between anticholinergic burden and compliance to treatment, and even fewer studies have investigated the possible effect of pharmacist interventional measures to enhance adherence in this group of individuals. Thus, the current study will address this gap by providing an estimate of anticholinergic burden and its relationship to treatment compliance in elderly, and also by investigating whether structured counselling interventions increase patient adherence.
2. MATERIAL AND METHODS
2.1. Study design and population
Following Institutional Ethics Committee (IEC no. 2347) approval, a prospective, observational study was carried out at MMIMSR, Mullana, Ambala (Haryana). The study was conducted in both inpatient and outpatient departments. In this study, the sample size of 350 patients was calculated. A random follow-up of 50 patients was also conducted to assess the effect of patient counseling on treatment compliance in the geriatric population. The patients were recruited according to our study’s inclusion and exclusion criteria. Patients of either gender who were ≥60 years were included in the study. Patients with an uncooperative attitude and an inability to answer questions were excluded from the study. The patients were informed about the complete study objectives and procedure. Patients were recruited after signing the informed consent. Baseline evaluations, like socio-demographic characteristics, age, gender, disease duration, ACB score, concomitant illness, and current medication, were assessed. The counselling sessions consisted of structured patient education covering the purpose and importance of prescribed medications, correct dosing schedules, possible side effects of anticholinergic drugs, use of pill organizers, alarms, pill reminder app (medication reminder), smartwatch, and telephonically Short Message Service (SMS) reminder according to the patient, Regular monitoring (Blood pressure, blood glucose, cholesterol, etc.) as it encourages continuing therapy, Involvement of family members or caregivers improves reminders, motivation, Benefits of techniques like yoga, meditation, or breathing exercises as it reduces stress and enhances attention, improving treatment compliance, Avoid alcohol or excessive caffeine, which may interfere with medications.
2.2. Assessment of anticholinergic burden
The overall impact of anticholinergic medicine was determined using the ACB. It is a clinical measure used to assess the long-term anticholinergic effects of medications, with a focus on impairments to cognitive function. Based on its anticholinergic activity, each medication is given a score between 0 and 3, where 0 indicates no activity, 1 potential effect, 2 indicates moderate effects, and 3 indicates strong effects. Higher scores signify a greater chance of falls, delirium, cognitive decline, and other adverse consequences. A patient’s overall ACB score is calculated by summing the scores of all the medications they are currently taking [18].
2.3. Assessment of patient treatment compliance
The adherence of patients to their medication regimens was evaluated using the Morisky medication adherence scale (MMAS)-4. Since its creation in 1986 by Morisky et al. [19], it has found extensive application in both clinical and research settings. The four questions on the MMAS-4 are designed to assess a patient’s medicine-taking habits. The purpose of the questions is to evaluate both deliberate and inadvertent non-adherence [20].
2.4. Statistical analysis
The data was analysed using IBM SPSS Statistics 29.0.2.0. The data was compiled and presented as mean ± SD and in numbers and percentages (%). The categorical variables were analysed using the chi-square test. The relationship between MMAS-4 and ACB Score was appraised using Pearson’s correlation coefficient. Multiple logistic regression was used to find the effect of adherence on confounding factors. The p-value ? 0.05 was considered statistically significant.
3. RESULT
A total of 430 patients of both genders were screened, out of which 350 geriatric patients were assessed for further assessment and outcome. This study also evaluates the follow-up of 50 randomly selected patients for 8 weeks to check the impact of patient counseling on treatment compliance. The mean age of the geriatric patient is 70.11 ± 6.36 (Age range 61–88 years), with 68.85% males and 31.14% females involved in the study. The socio-demographic characteristics and anticholinergic burden score of geriatric patients are summarized in Tables 1 and 2, respectively. About 27.15%of patients showed no anticholinergic burden, whereas 72.85% of patients had anticholinergic burden scored 1,2, and ≥3.
Table 1. Socio-demographic distribution in the Geriatric population.
| Variables | Geriatrics patients n = 350 (%) | p-value |
|---|---|---|
| Average age in years (mean ± SD) Range (years) | 70.11 (± 6.36) 61–88 (27) | – |
| Gender N (%) Male Female | 241 (68.85) 109 (31.14) | 0.31 |
| Smokers Non-Smokers | 183 (52.28) 167 (47.71) | 0.51 |
| Alcoholics Non-Alcoholics | 153 (43.71) 197 (56.28) | 0.01 |
| Literate Illiterate | 91 (26) 259 (74) | 0.56 |
The bold values are statistically significant (p > 0.05).
Table 2. ACB description in male and female geriatric population.
| ACB score | Male N (%) (n = 241) | Female N (%) (n = 109) |
|---|---|---|
| 0 | 69 (28.63) | 26 (23.85) |
| 1 | 49 (20.33) | 21 (19.26) |
| 2 | 32 (13.27) | 13 (11.93) |
| 3 | 39 (16.18) | 26 (23.85) |
| 4 | 20 (8.29) | 5 (4.58) |
| 5 | 7 (2.90) | 4 (3.67) |
| 6 | 10 (4.14) | 9 (8.26) |
| 7 | 3 (1.24) | 3 (2.75) |
| 8 | 2 (0.82) | 0 (0) |
| 9 | 6 (2.48) | 1 (0.92) |
| 10 | 4 (1.65) | 1 (0.92) |
72.9% of patients demonstrated an ACB score ≥1, while 27.1% had no burden. The highest proportion was observed in those with ACB = 1 (20%). Notably, 40% (n = 140) of patients had an ACB score ≥3, indicating a clinically significant burden. The distribution of ACB scores by gender revealed that 76.2% of females and 71.4% of males scored ACB ≥1 (Table 2).
The prevalence of anticholinergic symptoms is presented in Table 3. Cognitive impairment (29.0%) was the most commonly reported, followed by dizziness (18.8%), dry mouth (13.7%), and urinary incontinence (10.6%). Less frequent symptoms included delirium (9.8%) and falls (5.9%). The list of ACB drugs, prescribed to our study population, is depicted in Table 4. A total of 22 different drugs are being prescribed in geriatric patients. Levocetirizine (22.82%), ranitidine (16.18%), and quetiapine (10.37%) were the three most highly prescribed anticholinergic drugs or drugs with anticholinergic characteristics among all.
Table 3. Proportion of anticholinergic symptoms in geriatrics patients (N-255).
| Symptoms | N (%) |
|---|---|
| Cognitive impairment | 74 (29.02) |
| Dizziness | 48 (18.82) |
| Dry mouth | 35 (13.72) |
| Urinary incontinence | 27 (10.58) |
| Delirium | 25 (9.80) |
| Falls | 7 (2.74) |
| Dilated pupil | 25 (9.80) |
| Constipation | 14 (5.50) |
Table 4. Anticholinergic medicines in geriatrics with anticholinergic burden.
| Drugs | No. of drugs | % of drugs out of total anticholinergic (%) | ACB | ACB (Collectively) (ACB No. of drugs) |
|---|---|---|---|---|
| Levocetirizine | 55 | 22.8 | 1 | 55 |
| Ranitidine | 39 | 16.2 | 1 | 39 |
| Quetiapine | 25 | 10.4 | 3 | 75 |
| Risperidone | 21 | 8.7 | 1 | 21 |
| Olanzapine | 19 | 7.9 | 3 | 57 |
| Carbamazepine | 16 | 6.6 | 2 | 32 |
| Alprazolam | 12 | 5 | 1 | 12 |
| Paroxetine | 9 | 3.7 | 3 | 27 |
| Trihexyphenidyl | 9 | 3.7 | 3 | 27 |
| Amitriptyline | 7 | 3 | 3 | 21 |
| Metoprolol | 5 | 2.1 | 1 | 5 |
| Prednisolone | 5 | 2.1 | 1 | 5 |
| Hydroxyzine | 4 | 1.6 | 3 | 12 |
| Haloperidol | 4 | 1.6 | 1 | 4 |
| Furosemide | 3 | 1.2 | 1 | 3 |
| Cyproheptadine | 2 | 1 | 2 | 4 |
| Dicyclomine | 1 | 0.4 | 3 | 3 |
| Digoxin | 1 | 0.4 | 1 | 1 |
| Chlorthalidone | 1 | 0.4 | 1 | 1 |
| Diphenhydramine | 1 | 0.4 | 3 | 3 |
| Apiprazole | 1 | 0.4 | 1 | 1 |
| Nortriptyline | 1 | 0.4 | 3 | 3 |
Treatment compliance differed significantly between patients with and without anticholinergic burden in Table 5. In the non-ACB group, 43.15% of the geriatric patients had high compliance. However, in the geriatric patients who have ACB ≥1 having 8.62% high compliance, and 42.74 and 48.62% have medium and low compliance, respectively.
Table 5. Treatment compliance measurement ACB & Non-ACB patients.
| Geriatrics | Compliance | p- value | ||
|---|---|---|---|---|
| High n (%) | Medium n (%) | Low n (%) | ||
| Non-ACB | 41(43.15) | 35 (36.85) | 19 (20) | <0.001 |
| ACB≥1 | 22 (8.62) | 109 (42.74) | 124 (48.62) | <0.02 |
The bold values are statistically significant (p > 0.05).
The effect of pharmacist-led counseling on adherence is summarized in Table 6. At baseline, no patients demonstrated high compliance; however, after 8 weeks of follow-up, 20% achieved high compliance, while medium compliance improved to 56% and low compliance declined to 24% (p = 0.034).
Table 6. Impact of patient counseling on treatment compliance.
| Treatment compliance (8 weeks) | p-value | |||
|---|---|---|---|---|
| High n (%) | Medium n (%) | Low n (%) | ||
| Before CI | --- | 23 (46) | 27 (54) | <0.034 |
| After CI | 10 (20) | 28 (56) | 12 (24) | |
The bold values are statistically significant (p > 0.05).
CI: Clinical intervention.
As an anticholinergic burden, literacy and other factors affect treatment compliance, so follow-up was conducted in 50 randomly selected patients over 8 weeks to assess the impact of patient counseling on treatment compliance in the geriatric population (Table 6). After 8 weeks of patient counseling, 20% of the population has achieved high treatment compliance, while 56% and 24% of the population achieved medium and low treatment compliance, respectively (Table 6).
In this current study, we also applied regression analysis on our study data revealed that higher ACB scores were significantly associated with increased odds of medication non-adherence (OR = 1.32, 95% CI: 1.20–1.45, p = 0.001), indicating that each unit increase in ACB score was associated with a 32% higher likelihood of non-adherence. However, we did not find any significant correlation between ACB score and other factors like gender, smoking, drinking, literacy, and concomitant illnesses (p > 0.05), as shown in Table 7.
Table 7. Logistic regression analysis of confounding factors associated with medication non-adherence.
| Parameter | B (regression coefficient) | p value | OR | 95% CI |
|---|---|---|---|---|
| Age | −0.33 | 0.08 | 1.39 | 0.99–1.03 |
| Gender | −0.20 | 0.55 | 1.22 | 0.62–2.40 |
| Smoking | −0.20 | 0.58 | 0.82 | 0.41–1.65 |
| Drinking | −0.20 | 0.57 | 0.81 | 0.40–1.66 |
| Comorbidities | −0.01 | 0.60 | 0.98 | 0.94–1.03 |
| ACB | −0.28 | 0.001 | 1.32 | 1.20–1.45 |
| Literacy | −0.07 | 0.84 | 1.07 | 0.47–1.85 |
The bold values are statistically significant (p > 0.05).
4. DISCUSSION
This present study investigated anticholinergic burden and treatment compliance in geriatric patients. This study also explored the impact of patient counseling on treatment compliance in geriatric patients. In this study, we observed that approximately 75% of geriatric patients have ACB scores≥1. The present study also found that cognitive impairment, dizziness, and dry mouth are the most prominent anti-cholinergic symptoms experienced by geriatric patients. The geriatric patients who have an anticholinergic burden ≥1 have approximately 2.5 times worse treatment compliance than the patients who don’t have an ACB score. Interestingly, the ACB score significantly correlated (p ? 0.05) with treatment compliance. To the best of our knowledge, this is one of the first studies to investigate the anticholinergic burden and treatment compliance in geriatric patients, and the effect of clinical intervention in geriatric cases. Geriatric patients always have multiple comorbidities that require polypharmacy. Anticholinergic burden, which is becoming a risk factor for adverse events, cognitive impairment, dizziness, delirium, disability, falls, frailty, etc., is increased by polypharmacy [21]. In this current study, 75% of geriatric patients have an anticholinergic burden score of more than 1. Another study on the Malaysian population found that 72.84% of patients had an ACB score ≥1, which is similar to our study results [22]. A recent study on the German population has shown that the prevalence of anticholinergic burden was 53.7% [23]. Another study conducted in Poland by Wilczynski et al. [1] on the geriatric ward inpatients reported that 40.73% of patients had an ACB score ≥1 [1]. An Indian study by Chahine et al. [24] 79.6% of older persons with mental problems were using at least one anticholinergic medication. Overall, these results suggest that the European population has less ACB burden than the Asian population. This variation can be explained by systemic and cultural differences. In Europe, structured prescribing tools such as the STOPP-START criteria and ACB scales are widely implemented, enabling physicians to deprescribe and avoid inappropriate drug use [25]. European healthcare systems also emphasize routine medication reviews, clinical pharmacist involvement, and strict pharmacovigilance policies. In contrast, developing nations often lack structured geriatric care, and polypharmacy is more prevalent due to limited access to specialist services. Differences in prevalence across countries are influenced by prescribing culture, drug availability, healthcare structures, and regulatory policies. In this study, we also found that 76.15% of geriatric females & 71.37% of geriatric males had ACB ≥1. This study’s results suggest that female geriatric patients have slightly more anticholinergic burden than male geriatric patients. The females are more prone to anticholinergic burden due to polypharmacy, chronic conditions, and most importantly, hormonal differences [26]. A study in Germany by Reinold et al. [27] in the geriatric population, also supported that the prevalence of ACB ≥1 was greater in aged women than in aged men. Another Italian study by Boccardi et al. [28] claimed that aged women, using drugs with anticholinergic properties, resulted in increased cognitive impairment status as compared to aged men. A study by Kristensson et al. [21] stated that antihistaminic and antipsychotic drugs are commonly prescribed drugs in the geriatric population, having unknown side effects that affect cognitive functions. Similarly, in our study, 22.82% of levocetirizine, 16.18% of ranitidine, and 10.37% of quetiapine were the most frequently administered anticholinergics to geriatric patients. These antihistaminic and antipsychotic drugs have unknown adverse effects that affect cognition in geriatric patients. Another study by Salahudeen et al. [29] also claimed that many medications like antihistamines, antidepressants/antipsychotics, and neuroleptics could lead to anticholinergic adverse effects if used in combination with other drugs.
Also, research by Coupland. et al. [30] showed that there was a significant increase in adverse event risk (dementia, cognitive decline) by the use of antipsychotics in elderly patients. A study by Mur et al. [31] claimed that Medication treatment in geriatric patients should avoid antipsychotics and antihistaminic drugs as they cause dry eyes, which is an adverse effect of anticholinergic burden. Cognitive impairment was the most prominent adverse effect in our study (29.02%), followed by dizziness (18.82%), dry mouth (13.72%), and urinary incontinence (10.58%). This study’s results suggest that cognitive impairment is one of the most prominent adverse effects seen in the geriatric population. According to other research, taking drugs that have anticholinergic effects could increase your likelihood of acquiring an anticholinergic burden. Anticholinergic burden and cognitive impairment are said to have a clear and inversely proportional relationship; that is, people who take more anticholinergic medications did worse on cognitive tests, and high anticholinergic load raises the risk of cognitive adverse events, dementia development, and possibly even old age-related death [32–34]. The Studies by Rudolph [34] Pasina et al. [35] and Boccardi et al. [28] have shown that anticholinergic drug use in older adults is associated with a decline in cognitive status, as these drugs can impair brain function, leading to issues such as confusion, memory problems, resulting in non-compliance [28,34,35].
Geriatric patients already have poor compliance due to age factors, dementia, and other reasons. This current study also examined treatment compliance in geriatric patients, suggesting that drugs with anticholinergic activity are associated with poor treatment compliance in this patient population. It has already been proven that anticholinergic medications can adversely lead to discomfort and reduce the patient’s willingness to continue taking their medication as prescribed [36]. Also, a recent Turkish study showed treatment non-compliance in half of the patients, claiming that the consumption of drugs with anticholinergic activity had a strong impact on treatment compliance in geriatric patients [37]. In this research, we found that approximately 48.62% of geriatrics having ACB≥1 have low treatment compliance by using the Morisky medication adherence scale. Similarly, a study by Jambarsang et al. [38] showed 79.1% low treatment compliance by using the Morisky medication adherence scale in geriatrics [38]. In geriatrics, the impact can be even more obvious, as they are more susceptible to the cognitive and physical side effects of anticholinergic drugs, resulting in poor compliance, increased risk of falls, and overall decline in quality of life [39]. In this present study, we have performed a follow-up of 8 weeks and counseled the geriatric patients regarding treatment adherence, which resulted in an 18% increase in poor compliance in the geriatric patients.
By our data, the association between clinical intervention and level of compliance was statistically significant, suggesting that the involvement of a clinical pharmacist enhances the patient’s treatment compliance, especially in geriatric patients. Another study by Tavakoly et al. [40] claimed that the clinical intervention significantly improved the health outcomes, medication adherence, and self-efficacy among the older patients as compared to the control group. Also, a study by Lin et al. [41] suggested that (Comprehensive Geriatric Assessment) with clinical intervention, if included in hospitals, especially for older persons, enhances health outcomes [41]. Another study by Maheshwari et al. [42] claimed that patient counseling increased patient medication compliance.
According to our study, ACB is a significant predictor of medication adherence in geriatric populations. ACB makes it more difficult for people to adhere to their treatment, perhaps because anticholinergic drugs induce cognitive and functional problems. Our data shows that ACB affects adherence similarly for all patients, regardless of gender, smoking, drinking, or other health issues, which is different from some studies that find effects based on gender. Boccardi et al. [28] studied the impact of ACB on health and clinical outcomes of older persons with different levels of cognitive impairment, such as moderate cognitive impairment and Alzheimer’s disease. The study indicated that high ACB was strongly linked to adherence problems, especially in men [28]. According to Kersten et al. [43] lowering ACB enhances cognition, which might lead to better adherence. As per López-Álvarez et al. [36] Increased ACB is related to adherence problems, especially in males. Conversely, we do not find a statistically significant gender difference in the ACB and treatment compliance. The reason for the results may be that our study was conducted in older adults with multiple comorbidities, whereas previous studies often involved small groups of individuals with cognitive impairments due to dementia or a specific psychiatric diagnosis. Regional patterns of prescription and the existence of variability in access to healthcare resources are also possible factors contributing to this disparity.
5. CONCLUSION
The study concludes that the majority of geriatric patients had ACB more than 1. Cognitive impairment, dizziness, dry mouth, and urinary incontinence were the most commonly reported symptoms. Levocetirizine, ranitidine, and quetiapine were the three most highly prescribed drugs with anticholinergic properties. Patients with ACB> 1 had poor compliance. Pharmacist-led counselling led to improvement in medication compliance. The observed improvement in pharmacist-led counselling highlights the value of planned measures to reduce these variables. Clinicians will need to evaluate ACB regularly in the future when prescribing safer alternatives. The health systems must also implement pharmacist education and adherence programmes as an integral part of geriatric care. Besides improving adherence, the main goal of ACB is to maintain clinical outcomes and quality of life for the elderly population.
6. AUTHOR CONTRIBUTIONS
All authors made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; took part in drafting the article or revising it critically for important intellectual content; agreed to submit to the current journal; gave final approval of the version to be published; and agree to be accountable for all aspects of the work. All the authors are eligible to be author as per the International Committee of Medical Journal Editors (ICMJE) requirements/guidelines.
7. FINANCIAL SUPPORT
There is no funding to report.
8. CONFLICTS OF INTEREST
The authors report no financial or any other conflicts of interest in this work.
9. ETHICAL APPROVALS
The study protocol was approved by the Institutional Ethics Committee (IEC), of MM Institute of Medical Sciences & Research Hospital, Mullana-Ambala (Approval No.: IEC No. 2347).
10. DATA AVAILABILITY
All data generated and analyzed are included in this research article.
11. PUBLISHER’S NOTE
All claims expressed in this article are solely those of the authors and do not necessarily represent those of the publisher, the editors and the reviewers. This journal remains neutral with regard to jurisdictional claims in published institutional affiliation.
12. USE OF ARTIFICIAL INTELLIGENCE (AI)-ASSISTED TECHNOLOGY
The authors declare that they have not used artificial intelligence (AI)-tools for writing and editing of the manuscript, and no images were manipulated using AI.
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