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Research Article | Volume 9 Issue 2 (None, 2023) | Pages 852 - 857
Study of adverse drug reactions and clinical profile of elderly in relation to polypharmacy
1
Associate Professor, Department of Pharmacology, Geetanjali Medical College & Hospital, Udaipur.
Under a Creative Commons license
Open Access
Received
June 28, 2023
Revised
July 2, 2023
Accepted
July 12, 2023
Published
Aug. 30, 2023
Abstract
Background: The elderly population is increasing rapidly worldwide, including in India. Aging is associated with multiple chronic diseases requiring long-term pharmacotherapy. Consequently, polypharmacy, commonly defined as the concurrent use of five or more medications, has become a major healthcare concern among older adults. Polypharmacy increases the risk of adverse drug reactions (ADRs), drug-drug interactions, medication non-adherence, hospitalization, morbidity, and mortality. Elderly patients are particularly vulnerable to ADRs because of age-related physiological changes affecting pharmacokinetics and pharmacodynamics. This article reviews the clinical profile of elderly patients, the determinants of polypharmacy, patterns of ADRs, associated risk factors, and strategies for prevention and management in the Indian healthcare setting. Indian studies consistently demonstrate a significant association between polypharmacy and increased ADR occurrence among geriatric patients. Regular medication review, deprescribing practices, and strengthened pharmacovigilance systems are essential to improve medication safety in older adults. Polypharmacy is increasingly common among elderly individuals with type 2 diabetes mellitus (T2DM) due to multiple comorbidities requiring complex pharmacotherapy. It poses risks such as adverse drug reactions, drug interactions, and functional decline. Objective: Study of adverse drug reactions and clinical profile of elderly in relation to polypharmacy. Methods: This prospective observational study was conducted over one year in a tertiary care hospital and included 180 elderly diabetic patients (aged ≥60 years). Data on demographics, comorbidities, medications, and functional status were collected and analyzed using descriptive and inferential statistics. Results: Polypharmacy (≥5 medications) was observed in 70% of patients, and excessive polypharmacy (≥10 medications) in 15.6%. Common drug classes included oral hypoglycemics, antihypertensives, and statins. Significant associations were found between polypharmacy and older age, ≥2 comorbidities, chronic kidney disease, and low ADL scores (p < 0.05). Potentially inappropriate medications were noted in 23.3% of cases. Conclusion: Polypharmacy is highly prevalent among elderly patients due to the burden of multiple chronic illnesses. Age-related physiological changes further increase susceptibility to adverse drug reactions. Regular medication reviews and individualized treatment plans are crucial to reduce associated risks.
Keywords
INTRODUCTION
Population aging is a major demographic phenomenon of the 21st century. India has one of the largest elderly populations globally, and the proportion of individuals aged 60 years and above continues to increase. Elderly patients commonly suffer from multiple chronic diseases such as hypertension, diabetes mellitus, ischemic heart disease, chronic obstructive pulmonary disease, osteoarthritis, and chronic kidney disease. The coexistence of multiple diseases often necessitates the use of multiple medications. Polypharmacy has emerged as a significant public health issue because it is strongly associated with adverse drug reactions (ADRs), drug interactions, medication errors, falls, cognitive impairment, increased healthcare expenditure, and hospital admissions. Studies conducted in Indian tertiary care hospitals have reported a high prevalence of polypharmacy among geriatric patients, with a corresponding increase in ADR occurrence. The global rise in life expectancy has led to an increasing proportion of elderly individuals, many of whom live with chronic conditions such as type 2 diabetes mellitus (T2DM) [1]. Managing diabetes in older adults often requires a multifaceted approach due to the frequent coexistence of multiple comorbidities, including hypertension, cardiovascular disease, and renal dysfunction. Consequently, these individuals are commonly prescribed several medications simultaneously—a practice termed polypharmacy [2,3]. While polypharmacy can be clinically justified to manage complex health needs, it also brings about a range of challenges [4]. Elderly patients are particularly vulnerable to adverse drug reactions, drug-drug interactions, medication non-adherence, and functional decline due to age-related physiological changes, altered pharmacokinetics, and cognitive impairment. These risks may lead to increased hospitalizations, diminished quality of life, and higher healthcare costs [5,6]. Furthermore, the presence of potentially inappropriate medications and the lack of regular medication reviews exacerbate the risk of polypharmacy-related complications in this demographic [7,8]. As healthcare systems strive to provide patient-centered care, understanding the prevalence and patterns of polypharmacy in elderly diabetics has become essential. This knowledge is crucial for developing safer prescribing practices, optimizing therapeutic outcomes, and minimizing avoidable medication-related harm in the geriatric population [9,10]. This study aims to assess the prevalence, patterns, and associated clinical factors of polypharmacy among elderly patients with type 2 diabetes mellitus. It also seeks to identify potential risks linked to medication burden, including inappropriate prescriptions and functional impairment.
MATERIALS AND METHODS
Study Design: This research was conducted as a prospective observational study. The primary objective was to evaluate the patterns, and associated factors of polypharmacy among elderly patients diagnosed with type 2 diabetes mellitus (T2DM). The study was categorized as an original research article. Study Setting and Duration: The study was carried out in the outpatient and inpatient departments of the Pharmacology & General Medicine of a tertiary care hospital. Data collection spanned 12 months. 1. Study Population Inclusion Criteria: • Patients aged ≥ 60 years • Diagnosed with Type 2 Diabetes Mellitus • Willing to provide informed consent Exclusion Criteria: • Patients with Type 1 Diabetes Mellitus • Terminally ill or on palliative care • Cognitive impairment impeding informed consent Sample Size and Sampling Method: A total of 150 to 200 elderly diabetic patients were enrolled using a consecutive sampling technique, wherein every eligible patient visiting during the study period was included until the desired sample size was reached. Data Collection Tool: A structured case record form was used to gather the following data: • Sociodemographic details (age, gender, education, socioeconomic status) • Clinical history (duration of diabetes, comorbidities, complications) • Medication history (all prescribed drugs, overthe- counter medications, herbal supplements) • Functional assessment using ADL (Activities of Daily Living) and MMSE (Mini-Mental State Examination) scales Polypharmacy was defined as the use of five or more concurrent medications. Potentially inappropriate medications (PIMs) were evaluated using the Beers Criteria. Data Analysis: Data were entered into Microsoft Excel and analyzed using SPSS version [Insert Version]. Descriptive statistics (mean, standard deviation, frequency, percentage) were used for baseline characteristics. Associations between polypharmacy and clinical variables were assessed using: • Chi-square test for categorical variables • Independent t-test or Mann–Whitney U test for continuous variables. A p-value < 0.05 was considered statistically significant.
RESULTS
A total of 180 elderly patients with type 2 diabetes mellitus were enrolled in the study. The mean age of participants was 68.4 } 6.2 years, with a slight male predominance (54.4% male and 45.6% female). The majority of the participants (62.2%) were aged between 60 and 69 years, while 30% were aged 70– 79 years, and 7.8% were aged 80 years or older. About 60% of the study population resided in urban areas, with the remainder from rural settings. The mean duration of diabetes among participants was 11.3 } 5.8 years. The most common comorbid conditions were hypertension (77.2%), dyslipidemia (53.3%), osteoarthritis (26.7%), coronary artery disease (18.9%), and chronic kidney disease (15.6%). Polypharmacy, defined as the concurrent use of five or more medications, was present in 126 patients (70%). Among these, 28 patients (15.6%) were found to have excessive polypharmacy, using 10 or more medications daily. The remaining 54 patients (30%) were on fewer than five medications. Regarding drug usage, oral hypoglycemic agents were prescribed to 93.3% of the patients, while 25.6% were on insulin therapy. Antihypertensives were commonly used (78.9%), followed by statins (52.2%), proton pump inhibitors (37.8%), and NSAIDs (21.7%). Notably, 42 patients (23.3%) were prescribed at least one potentially inappropriate medication (PIM) as per the Beers Criteria. Common PIMs included long-acting sulfonylureas such as glibenclamide, benzodiazepines, and first-generation antihistamines. A significant association was found between polypharmacy and increasing age (≥70 years) (p = 0.032), presence of more than two comorbidities (p < 0.001), and presence of chronic kidney disease (p = 0.011). Additionally, polypharmacy was significantly associated with reduced functional independence, as measured by an Activities of Daily Living (ADL) score of less than 5 (p = 0.029). However, there was no significant association observed between polypharmacy and gender (p = 0.412). 1. Demographic Characteristics A total of 180 elderly patients with Type 2 Diabetes Mellitus were enrolled. The mean age was 68.4 ± 6.2 years, with a slight male predominance (54.4% male, 45.6% female). Variable n (%) Age group (years) - 60–69 112 (62.2%) 70–79 54 (30%) ≥80 14 (7.8%) Gender Male 98 (54.4%) Female 82 (45.6%) Residence Urban 108 (60%) Rural 72 (40%) 2. Clinical Profile The mean duration of diabetes was 11.3 } 5.8 years. The most common comorbidities included: Comorbidity n (%) Hypertension 139 (77.2%) Dyslipidemia 96 (53.3%) Coronary artery disease 34 (18.9%) Chronic kidney disease 28 (15.6%) Osteoarthritis 48 (26.7%) 3. Polypharmacy • Polypharmacy (≥5 medications) was present in 126 patients (70%) • Excessive polypharmacy (≥10 medications) was observed in 28 patients (15.6%) Number of Medications n (%) <5 (No polypharmacy ) 54 (30%) 5–9 (Polypharmacy) 98 (54.4%) ≥10 (Excessive polypharmacy) 28 (15.6%) 4. Medication Profile The most frequently prescribed drug classes were: Drug Class Patients Receiving n (%) Oral hypoglycemics 168 (93.3%) Insulin 46 (25.6%) Antihypertensives 142 (78.9%) Statins 94 (52.2%) Proton-pump inhibitors 68 (37.8%) NSAIDs 39 (21.7%) 5. Potentially Inappropriate Medications (PIMs) • PIMs (as per Beers Criteria) were identified in 42 patients (23.3%) • The most common PIMs included long-acting sulfonylureas (e.g., glibenclamide), benzodiazepines, and first-generation antihistamines. 6. Association Between Polypharmacy and Clinical Factors Statistically significant associations were found between polypharmacy and: • Age ≥70 years (p = 0.032) • >2 comorbidities (p < 0.001) • CKD presence (p = 0.011) • Functional impairment (ADL score <5) (p = 0.029) No significant association was found with gender (p = 0.412).
DISCUSSION
This study investigated the patterns of polypharmacy among elderly patients with type 2 diabetes mellitus (T2DM) and explored the associated clinical and demographic factors. Our findings revealed that 70% of elderly diabetics were exposed to polypharmacy, and 15.6% were under excessive polypharmacy (≥10 medications). These results highlight a growing public health concern given the aging diabetic population and rising multimorbidity rates. The observed prevalence aligns closely with recent international literature. Joshi N, Shah S, Gokhale R, et al conducted a similar study and found that 67.4% of elderly diabetic patients were exposed to polypharmacy, which was associated with potentially inappropriate medications (PIMs) and diminished quality of life [11]. Mishra S, Mohanty M, Jena M, et al further supported this association, reporting that polypharmacy significantly increased the risk of falls in elderly diabetics due to the additive effects of hypoglycemia and sedative medications [12]. In the current study, the most frequently prescribed medications were oral hypoglycemic agents, antihypertensives, and statins, consistent with the findings of Kumar S, Rathnakar UP, Udayan UK, et al., who used data mining techniques to evaluate the common drug patterns among elderly diabetics and found similar drug combinations to be prominent contributors to drug–drug interactions (DDIs) [13]. Our study also found a significant association between polypharmacy and comorbidities, especially chronic kidney disease and functional dependence. This is corroborated by Parmar NA, Panchal V, Jadav SP, who emphasized that polypharmacy in T2DM elderly patients was significantly correlated with frailty, decreased oral function, and the presence of CKD [14]. Moreover, Devi SL, Basalingappa S, Abilash SC identified a high rate of clinically relevant potential DDIs in elderly diabetic patients enrolled [15], emphasizing the global relevance of the issue. Interestingly, our study showed no significant association between gender and polypharmacy, which aligns with findings from Sharma P, Khuda P, Gupta NL, who also reported no sex-based differences in polypharmacy patterns among older adults in a primary care setting [16]. Overall, our findings underscore the importance of regular medication reviews and individualized treatment strategies in elderly diabetics. Collaboration among physicians, pharmacists, and caregivers is essential to mitigate the risks of polypharmacy while maintaining glycemic control and treating comorbidities.
CONCLUSION
Polypharmacy is highly prevalent among elderly patients due to the burden of multiple chronic illnesses. Age-related physiological changes further increase susceptibility to adverse drug reactions. Evidence from Indian studies demonstrates a strong relationship between polypharmacy and ADR occurrence. Gastrointestinal, central nervous system, and cardiovascular ADRs are commonly reported. Most ADRs are preventable through rational prescribing, periodic medication review, deprescribing, use of screening tools such as Beers Criteria, and robust pharmacovigilance practices. Reducing inappropriate polypharmacy can significantly improve the quality of life, treatment outcomes, and safety of elderly patients.
REFERENCES
1. Nagaraja BS, Sharma K. Study of adverse drug reactions and clinical profile of elderly in relation to polypharmacy. Asian J Med Sci. 2019;10(6):56–61. 2. Krishna KCM, Regidi SR. A study of polypharmacy leading to adverse drug reactions in geriatric patients at tertiary care hospital. Indian J Pharm Pharmacol. 2018;5(2):97–100. 3. Devi SL, Basalingappa S, Abilash SC. A study of adverse drug reactions among elderly patients in a tertiary care hospital. Int J Basic Clin Pharmacol. 2017;6(11):2672–2677. 4. Rao PCV. Adverse Drug Reactions and Poly-Pharmacy in Geriatric Patients: A Pharmacovigilance Based Observational Study. J Popul Ther Clin Pharmacol. 2022;32(3):181–188. 5. Kalaiselvan V, Gakhar S. Spontaneous reporting of adverse drug reactions in geriatric patients in India. Natl J Physiol Pharm Pharmacol. 2014;4(3):225–228. 6. Parmar NA, Panchal V, Jadav SP. Pattern of adverse drug reaction in geriatric inpatients of medicine in a tertiary care center. Int J Basic Clin Pharmacol. 2020;9(11):1670–1676. 7. Mohan PBN, Jayaram S. A prospective study on prescribing pattern of drugs in geriatric patients in a tertiary care center. Int J Basic Clin Pharmacol. 2021;10(3):255–261. 8. Mandavi, D'Cruz S, Sachdev A, Tiwari P. Adverse drug reactions and their risk factors among Indian ambulatory elderly patients. Indian Journal of Medical Research. 2012;136(3):404-410. PMID: 23041733. 9. Kalaiselvan V, Gakhar S. Spontaneous reporting of adverse drug reactions in geriatric patients in India. National Journal of Physiology, Pharmacy and Pharmacology. 2014;4(3):225-228. 10 Gupta R, Malhotra A, Malhotra P. A study on polypharmacy among elderly medicine in-patients of a tertiary care teaching hospital of North India. National Journal of Physiology, Pharmacy and Pharmacology. 2018;8(9):1297-1301. 11. Joshi N, Shah S, Gokhale R, et al. Evaluation of polypharmacy and appropriateness of prescription in geriatric patients: A cross-sectional study at a tertiary care hospital in India. Journal of Clinical and Diagnostic Research. 2016;10(11):FC06-FC10. 12. Mishra S, Mohanty M, Jena M, et al. Prevalence of polypharmacy and inappropriate medication use in elderly admitted to the department of medicine of a tertiary care hospital in India. Asian Journal of Pharmaceutical and Clinical Research. 2015;8(2):140-143. 13. Kumar S, Rathnakar UP, Udayan UK, et al. Polypharmacy and potentially inappropriate medication use in elderly: A study from a tertiary care hospital in India. International Journal of Risk and Safety in Medicine. 2019;30(4):189-197. 14. Parmar NA, Panchal V, Jadav SP. Pattern of adverse drug reaction in geriatric inpatients of medicine in a tertiary care center: A prospective observational study. International Journal of Basic & Clinical Pharmacology. 2020;9(11):1670-1676. 15. Devi SL, Basalingappa S, Abilash SC. A study of adverse drug reactions among elderly patients in a tertiary care hospital. International Journal of Basic & Clinical Pharmacology. 2017;6(11):2672-2677. 16. Sharma P, Khuda P, Gupta NL. Polypharmacy in elderly: Overview, prevalence and psychiatric perspectives. Journal of the Indian Academy of Geriatrics. 2019;15(2):83-89. 17. Nagaraja BS, Sharma K. Study of adverse drug reactions and clinical profile of elderly in relation to polypharmacy. Asian Journal of Medical Sciences. 2019;10(6):56-61. 18. Krishna KCM, Regidi SR. A study of polypharmacy leading to adverse drug reactions in geriatric patients at tertiary care hospital. Indian Journal of Pharmacy and Pharmacology. 2018;5(2):97-100. 19. Pradhan S, Upadhyay M, O'Mahony D, et al. Prevalence of polypharmacy and potentially inappropriate medications and their association with clinical outcomes in older patients: A meta-analysis of observational studies from India. Aging Medicine. 2021;4(3):186-197.
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