A CROSS-SECTIONAL STUDY ON POLYPHARMACY IN ELDERLY PATIENTS AT A TERTIARY CARE HOSPITAL OF TRIPURA

A CROSS-SECTIONAL STUDY ON POLYPHARMACY IN ELDERLY PATIENTS AT A TERTIARY CARE HOSPITAL OF TRIPURA

Shubhaleena Debnath, Prithul Bhattacharjee, Lakshman Das *, Debasree Bhaumik, Ranjib Ghosh and Arindam Datta

Department of Pharmacology, Tripura Medical College & Dr. BRAM Teaching Hospital, Agartala, Tripura, India.

ABSTRACT: Background: There is a significant link between polypharmacy and the emergence of adverse effects, drug interactions, and increased mortality among elderly patients. Polypharmacy and inappropriate prescription are matters of concern in elderly individuals; therefore, this study was done to find the pattern of polypharmacy among elderly patients. Methodology: A cross-sectional study was carried out at Tripura Medical College & Dr. B. R. Ambedkar Memorial Teaching Hospital (TMC) for a period of 12 months for elderly patients. Polypharmacy was analyzed by counting the number of medications per prescription. Each prescription drug was analyzed for overprescription, under-prescription, and inappropriateness individually. Baseline data were represented by suitable tables & figures and expressed in frequency, percentage, mean & standard deviation. The Chi-square test was applied to find out any statistical association. P value < 0.05 was considered statistically significant. Results: 444 elderly (65 years & above) patients attending medicine OPD were interviewed individually. Our study showed that 36.93% of the patients were receiving polypharmacy. There was a significant association between overprescription or underprescription and comorbidities like diabetes, hypertension with diabetes, and other comorbidities. About 23.87% of patients received an inappropriate prescription. As per MAI criteria, significant inappropriateness was found in prescriptions with chronic kidney disease. Conclusion: The study can help in judicious selection of drugs while prescribing for the elderly individual in order to prevent the ill effects of polypharmacy.

Keywords: Polypharmacy, Overprescription, Underprescription, Inappropriateness

INTRODUCTION: India’s population aged 60 years & above is projected to increase over the next decade ¹. An estimated 50% of elderly people in India suffer from at least one chronic disease that requires lifelong medication ². Conventionally, “elderly” is defined as a chronological age of 65 or older ³.

Older adults suffer from multiple comorbidities and seek medical advice from different physicians simultaneously. They are also the highest consumer of drugs. As a result, there is an increased chance of polypharmacy. Above all, there are declines in immunity and age-related physiological changes in this age group ⁴.

All these factors lead to adverse drug reactions (ADRs) in the elderly. According to World Health Organization (WHO) polypharmacy is defined as ‘the administration of many drugs at the same time or the administration of an excessive number of drugs ⁵. Polypharmacy is considered if the patient receives five or more concurrent medications ⁶. Overuse of medication carries major health risks, especially among the elderly. There is a significant link between polypharmacy and the emergence of adverse effects, drug interactions, and increased mortality ⁷. Polypharmacy often makes patients confuse trying to remember the drug regimen & leads to poor compliance as well as wastage of money. Some drugs pose special risks to older people, for example, prolonged sedation and increased risk of falls with long-acting benzodiazepines or increased risk of upper gastrointestinal bleeding with nonsteroidal anti-inflammatory drugs (NSAIDs) ⁸.

Prescriptions of such drugs are potentially inappropriate. Potentially inappropriate medications (PIMs) are considered when drugs outweigh the risk of an adverse event over their clinical benefit, particularly when there are safer or more effective alternative therapies for the same condition. The causes which lead to inappropriate prescribing may be lack of updated knowledge, imprecise diagnosis, patient overload, unrealistic claims by manufacturers, patients' demand etc. ⁹. The use of PIMs is common in elderly patients & is often associated with increased morbidity & mortality, increased cost, and decreased quality of life ⁵. Though polypharmacy and inappropriate prescription are matters of concern, few literatures are available in the northeastern states of India. In this study, the polypharmacy pattern and prescription appropriateness were evaluated in elderly patients at Tripura Medical College & Dr. B.R. Ambedkar Memorial Teaching Hospital (TMC).

Aim & Objectives:

AIM: To study the pattern of polypharmacy among elderly patients.

Objectives:

1. To find out the distribution of comorbidities among different age groups in elderly patients.
2. To assess the association between comorbidities and polypharmacy.
3. To determine the appropriateness (overprescribing, underprescribing, and inappropriate prescribing) of prescriptions among the study population.

MATERIALS AND METHODS:

Study Design: Cross-sectional study.

Study Area: TMC

Study Setting: Medicine out Patient Department (OPD) and Department of Pharmacology.

Study Period: 12 months.

Study Population: Elderly patients of 65 years & above.

Sample size: Sample size is calculated based on the expected proportion of people aged 65 years & above receiving polypharmacy as 52% as per previous studies ^{6, 35}. Taking 10% as relative precision at 90% power and confidence level of 95%, the sample size is found to be 355. Adding 20% as non-responders, the final sample size is 444 geriatric patients.

Inclusion Criteria: Both male and female patients aged 65 years and above attending medicine OPD were included in the study.

Exclusion Criteria: Herbal medicines were excluded for analyzing their appropriateness, as they are not included in any of the standard criteria.

Study Tools & Techniques:

Study Tools: To assess polypharmacy, number of drugs per prescription was counted. Polypharmacy was considered if the patient receives five or more concurrent medications ^{5, 9, 10, 17}.

• To assess the appropriateness of prescription in elderly following criteria were used -

Beers Criteria (2015 Version) ¹⁹: It contains fifty-three (53) inappropriate medications/medication classes, which are divided into five categories as follows:

1. Criteria for PIM use in older adults.
2. Criteria for PIM use in older adults due to drug-disease or drug-syndrome interactions that may exacerbate disease
3. Criteria for PIMs to be used with caution in elderly.
4. Criteria for potentially clinically important non-anti-infective drug-drug interactions that should be avoided in elderly.
5. Criteria for non-anti-infective medications that should be avoided or need dose adjustment according to kidney function.

Screening Tool of Older Person’s Prescriptions (STOPP) Criteria ²⁰: It has 65 criteria categorized under different physiological systems & gives information regarding drugs to be avoided in certain conditions.

Screening Tool to Alert to Right Treatment (START) Criteria ²⁰: It includes 23 criteria under various physiological systems & focuses on drugs to be prescribed for certain conditions.

Medication Appropriateness Index (MAI) ³⁶: It consists of 10 questionnaire scales with scores from 0-3.

1. If a drug is ‘Appropriate’ or ‘marginally appropriate, ’a score of zero is given to that drug. Each of the 10 criteria of the MAI that is considered ‘Not appropriate’ is given a maximum score of 1, 2 or 3 for each drug.
2. Weight of three is given for indication and effectiveness.
3. Weight of two is assigned to dosage, correct directions, practical directions, and drug-drug interactions.
4. One weight is assigned to drug-disease interactions, expense, duplication, and duration.
5. This, therefore, results in a total combined score of 0 to 18 (0 meaning the drug is appropriate and 18 representing maximal inappropriateness).
6. Combining the total MAI scores for each prescribed drug will yield a score for each patient.
7. The total score per patient will depend on the number of drugs a patient is on. For example, if a patient is on one drug, the minimum score would be 0, and the maximum score is 18; whilst if the patient is on 2 drugs, the minimum score per patient is 0 with a maximum inappropriateness of 36.

Study Technique: The study was conducted after obtaining informed written consent from each patient in their language. Each patient was interviewed individually, and all the relevant information about the prescription was recorded in a predesigned proforma. Polypharmacy was analyzed by counting the number of medications per prescription. Drug combinations were considered as a single drug. Each prescription drug was individually analyzed for overprescription by Beers and STOPP, under prescription by START and inappropriate by MAI criteria, and was considered appropriate or inappropriate. After analyzing all the individual drugs of a prescription, if any of the drugs come out as unfitting to any of the criteria, the prescription was considered inappropriate.²³If a prescription becomes appropriate by using one criteria, it may be considered inappropriate by another criterion. Moreover, one prescription can be inappropriate by more than one criterion also.

Ethical Approval: -Ethical Approval was obtained from the Institutional Ethics Committee as per notification No.F.3 (PO-75)/Inst. Ethical Com./SFTMC/2010-11/11365-11377.

Confidentiality: -Was strictly maintained for each individual patient.

Statistical Analysis:  -Data was entered in an excel sheet and analyzed using SPSS (Statistical Package for Social Sciences) version 20. Baseline data were represented by suitable tables & figures and expressed in frequency, percentage, mean & standard deviation. The Chi-square test was applied to find out any statistical association. P value < 0.05 was considered statistically significant.

RESULTS:

Distribution of Study Population: A total of 444 patients were included in the study. Among them, 273 (61.5%) were males & 171 (38.5%) were females. Gender and age group-wise distribution are shown in Table 1.

TABLE 1:  DISTRIBUTION OF STUDY POPULATION ACCORDING TO GENDER AND AGE   [N = 444]

Distribution of Comorbidities: The distribution of comorbidities according to the different age group is shown in Table 2. Out of 444 patients, a total 212 patients were suffering from various comorbid conditions like hypertension, diabetes, hypertension with diabetes, chronic kidney disease (CKD) & others. Others include anaemia, atrial fibrillation, autoimmune hepatitis, benign hypertrophy of prostate (BPH), coronary artery disease, chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), cerebrovascular disease (CVA), dyslipidaemia, dyspepsia, hypothyroidism, liver diseases, osteoarthritis, parkinsonism, tuberculosis & valvular defect.

Hypertension was found to be the commonest comorbidity which was seen in 92 (43.40%) patients. Among these 92 patients, 51(55.40%), 31(33.70%), 5(5.40%), and 5(5.40%) patients were from the age groups of 65-70 years, 71-80 years, 81-90 years and above 90 years respectively. Diabetes was present in 30 (14.20%) patients, of which 21(70%) patients were between 65-70 years age and 9 (30%) patients were between 71-80 years age. No patients above the age of 80 years had only diabetes as a comorbid condition. There were 31(14.60%) patients having both hypertension and diabetes as a comorbidity. Among them 18 (58%), 11 (35.60%) & 2 (6.40%) patients belong to 65-70 years, 71-80 years, 81-90 yearsand none from more than 90 years age group.A total 12 (5.60%) patients had chronic kidney disease & the age group wise distribution was 04 (33.30%) number of patients in each age group of 65-70 years, 71-80 years, 81-90 years and none above 90 years. 47(22.20%) out of 212 patients were suffering from other comorbidities. The number of patients in different age group were 27 (57.40%), 14 (29.80%), 3 (6.40%) & 3 (6.40%) in 65-70 years, 71-80 years, 81-90 years and above 90 years age group respectively.

TABLE 2:  DISTRIBUTION OF COMORBIDITIES ACCORDING TO AGE GROUP [N =212]

The figures in parentheses indicate percentages.

Distribution of Drug(s) Per Prescription: Table 3 shows drug(s) distribution per prescription. A total 1862 number of drugs were prescribed among 444 prescriptions. A minimum one and maximum nine drugs were prescribed in a single prescription.

There were 06 (1.4%) prescriptions with a single drug. A number of prescriptions having two and three drugs were 65 (14.6%) and 99 (22.2%), respectively. Majority of prescriptions had four number of drugs which was found to be 110 (24.8%) out of 444 prescriptions. There were 80 (18%), 40 (9%), and 12 (2.7%) numbers of prescriptions containing five, six and seven drugs, respectively.

Some of the prescriptions contained even up to eight & nine number of drugs and their frequency were 13 (2.9%) and 19 (4.3%), respectively. Average number of drug per prescription was found to be 4.2.

TABLE 3: DISTRIBUTION OF DRUG(S) PER PRESCRIPTION [N = 444]

Distribution of Prescriptions with Polypharmacy: The distribution of polypharmacy according to the age category was shown in Table 4. 164 (36.93%) out of 444 patients received polypharmacy, i.e., five or more drugs in a prescription.

94 (57.32%) patients receiving polypharmacy were between 65 and 70 years old. The remaining 45 (27.44%), 18 (10.98%), and 7 (4.26%) geriatric patients belonged to the age groups 71-80 years, 81-90 years, and above 90 years, respectively. We found 280 (63.07%) patients who did not receive polypharmacy in their prescriptions. Out of 280 patients, 163 (58.21%) patients belonged to 65-70 years, 91 (32.50%) patients belonged to 71-80 years, 22 (7.86%) patients belonged to 81-90 years & 4 (1.43%) patients belonged to above 90 years of age group.

TABLE 4: DISTRIBUTION OF PRESCRIPTIONS WITH POLYPHARMACY ACCORDING TO AGE GROUP [N = 444]

The figures in parentheses indicate percentage.

Association between Comorbidities and Polypharmacy: One of the objectives of this study was to find the association between comorbidities and polypharmacy shown in Table 5 & Fig. 1. The Chi-square test was applied to find out this association. Out of total 444 patients, 92 (20.73%) patients were hypertensive, and the remaining 352 (79.27%) patients were non-hypertensive as single comorbidity. It was observed that 34 (36.95%) hypertensive patients and 109 (30.96%) non-hypertensive patients received polypharmacy. On the other hand, 58 (63.05%) hypertensive patients and 243 (69.03%) non-hypertensive patients did not receive polypharmacy. Though polypharmacy was more in hypertensives than non-hypertensives, no significant association was found between hypertension as comorbidity & polypharmacy (P= 0.27).

TABLE 5: ASSOCIATION BETWEEN COMORBIDITIES AND POLYPHARMACY [N=444]

The figures in parenthesis indicate percentages. *P < 0.05 taken as statistically significant based on the Chi-square test.

FIG. 1: ASSOCIATION BETWEEN COMORBIDITY & POLYPHARMACY

Out of 30 diabetic patients (as single comorbidity) 12 (40%) patients received polypharmacy. Whereas among 414 non-diabetic patients, polypharmacy was received by 97 (23.43%) patients. Thus, patients with diabetes received more polypharmacy than patients without diabetes. A statistically significant association was found between diabetes as comorbidity & polypharmacy (p = 0.04). 31 patients had both hypertension and diabetes as a comorbidity. 22 patients among them received polypharmacy and 9 patients didn’t receive polypharmacy. The presence of both hypertension and diabetes was significantly associated with polypharmacy (p=0.001). All 12 patients suffering from chronic kidney disease (CKD) as comorbidity received polypharmacy. Forty-seven patients were suffering from other comorbidities like anaemia, atrial fibrillation, autoimmune hepatitis, benign hypertrophy of the prostate (BPH), coronary artery disease, chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), cerebrovascular disease (CVA), dyslipidemia, dyspepsia, hypothyroidism, liver diseases, osteoarthritis, parkinsonism, tuberculosis & valvular defect. Among them, 29 patients received polypharmacy, and 18 didn’t, which again showed a significant association with polypharmacy with a p-value of 0.001.

Proportion of Patients Receiving Overprescription and Underprescription: Overprescriptions were analyzed by Beers & STOPP criteria and underprescription by START criteria. Out of total 444 prescriptions, 178 (40.10%) prescriptions were overprescribed, and 9 (2.02%) prescriptions were underprescribed. A total 187 (42.12%) prescriptions were inappropriate (over and underprescribed). The remaining 257 (57.88%) prescriptions were appropriate as per Beers, STOPP & START criteria. All 187 inappropriate prescriptions were again analyzed according to various comorbidities. The distribution of overprescription & underprescription about various comorbidities are shown in Table 6. Association between in appropriateness of prescriptions (overprescription & under-prescription) and comorbidities were also analyzed & the data are displayed in Table 7 & Fig. 2. Out of 92 prescriptions of hypertension, a total 40 (43.47%) prescriptions were inappropriate and the remaining 52 (56.52%) prescriptions were appropriate. On the other hand, out of 352 prescriptions without hypertension (as single comorbidity) 205 (58.24%) prescriptions were appropriate & 147 (41.76%) prescriptions were inappropriate.

No statistical significance was found between prescriptions with hypertension (as single comorbidity) & their appropriateness (P=0.766). Similarly, there was no statistical significance between prescriptions with chronic kidney disease (CKD) & their appropriateness (P=0.08). Among 30 prescriptions with diabetes, 25 prescriptions were considered appropriate, which was statistically significant (P = 0.001).

TABLE 6: PATIENTS RECEIVING OVERPRESCRIPTION AND UNDERPRESCRIPTION

TABLE 7:  ASSOCIATION OF OVERPRESCRIPTION & UNDERPRESCRIPTION WITH COMORBIDITIES

The figures in parentheses indicate percentages. *P < 0.05 taken as statistically significant based on the Chi-square test.

On the other hand, 26 prescriptions having both hypertension & diabetes were considered inappropriate of 31 prescriptions which were statistically significant (P = 0.001). Out of 47 prescriptions with other comorbidities, 29 prescriptions were also inappropriate (P = 0.001). There were 232 prescriptions without any comorbidities. Among them, 153 prescriptions were appropriately prescribed which was statistically significant       (P = 0.001).

FIG. 2: ASSOCIATION OF OVERPRESCRIPTION & UNDERPRESCRIPTION WITH COMORBIDITIES

Appropriateness of Prescription: Appropriateness of prescriptions by MAI criteria was evaluated separately. The distribution of appropriateness according to comorbidity is shown in Table 8 & Fig. 3. Out of all patients, 212 patients were suffering from various comorbidities, as mentioned earlier in Table 8 & remaining 232 patients were without any comorbid condition. Among all patients, 106 (23.87%) patients received inappropriate and 338 (76.13%) received appropriate prescriptions.

TABLE 8: APPROPRIATENESS OF PRESCRIPTION (AS PER MAI CRITERIA)

The figures in parentheses indicate percentages. *P < 0.05 taken as statistically significant based on the Chi-square test.

FIG. 3: APPROPRIATENESS OF PRESCRIPTION (AS PER MAI CRITERIA)

Among 92 prescriptions with hypertension, 25 (27.17%) were inappropriate & 67 (72.83%) were appropriate. 352 patients were not suffering from hypertension as single comorbidity; among them, 81 (23.01%) received inappropriate & 271 (76.99%) received appropriate prescriptions. No significant association was found between prescriptions with hypertension & their appropriateness (P=0.31). Similarly, prescriptions with diabetes (as single comorbidity), hypertension with diabetes, and other comorbidities did not show any significant correlation with their appropriateness. Chronic kidney disease was seen in 12 patients. Out of that, 09 patients received significantly inappropriate prescriptions (P=0.001). No significant association was also found between prescriptions without any comorbidity with their appropriateness (P= 0.06).

DISCUSSION: The present study evaluated the polypharmacy and appropriateness of prescriptions in geriatric patients attending a tertiary care hospital. In this study, polypharmacy was defined as receiving five or more medications. This study included patients aged 65 years & above, and the mean age was 71.45 ± 6.81 years. The average number of medications per prescription was 4.2. Our study showed that 36.93% of the geriatric patients were receiving polypharmacy. Among the study participants in our study, there was a male preponderance (61.5%) compared to females (38.5%). In contrast, the distribution of gender was 54.6% male & 45.3% female in a study done by Rakesh KB et al.⁶ Lee SJ et al. ²² found 55% male & 45% female participants in their study. The mean age of the patients in our study was 71.45 ± 6.81 years, whereas the mean age (in years) was 55.60 ± 13.86, 67.45 ± 6.992 & 69.37 ± 7.42 in some other studies ^{37, 30, 39}. Patients were suffering from various comorbidities, with hypertension being the commonest (43.40%). This is comparable to Rakesh KB et al.⁶, which also found that hypertension was the most common comorbid condition (75.4%). Hypertension & diabetes were also found to be common comorbidities in other studies ^{40, 41, 42}. The prevalence of polypharmacy was 36.93% in our study, which was comparable to that of the studies done by Golchin N et al. (39.4%) & Slabaugh SL et al. (35.6%) ^{15, 43}.

Various authors found the higher proportion of polypharmacy as 66.2%, 78%, 60% & 89%in their studies ^{6, 27, 31, 42}. On the other hand, some of the studies showed better prescribing patterns in terms of polypharmacy with a proportion of 13.85%, 23.1% & 26.7% ^{38, 39, 16}. The proportion of polypharmacy in the present study was higher in the 65-70 years age group, which was comparable to the study by Mamun K. et al. ³¹. Some other authors showed a higher proportion of polypharmacy in 70–79 years age group in their studies ^{6, 44}.

 One of the major causes of polypharmacy is multiple health conditions requiring the use of several medications. In our study, a significant increase in polypharmacy was associated with diabetes and hypertension with diabetes as comorbidities. Zabihi A. et al. ³⁹ and Al. Ameri M. N. et al.⁴² also found that heart diseases, diabetes & hypertension were associated with polypharmacy. The appropriateness of prescriptions was evaluated using various criteria like Beers criteria, STOPP criteria, START criteria & MAI criteria. Researchers across the world widely use these criteria. Moreover, these criteria are updated regularly. Based on the above criteria, 44.59% of prescriptions were inappropriate in our study. We found that 40.10% and 2.02% were overprescription & underprescription, respectively. 23.87% of prescriptions were inappropriate as per MAI criteria. Significant inappropriateness was found in prescriptions having hypertension with diabetes, CKD, and other (mentioned above) comorbidities. Prescriptions with diabetes as single comorbidity were found to be appropriate. Various studies have reported an inappropriateness of prescription to an extent of 32%, 53%, 62.5%, 66% and76.6% respectively ^{45, 46, 47, 49, 41}. About 16.89% patients received potentially inappropriate medications as per Beers criteria. Drugs like clonazepam, tramadol, amitriptyline, prazosin, digoxin, dimenhydrinate were inappropriately prescribed. The proportion of inappropriate prescriptions by AGS Beers Criteria2015 was found to be 8.45% by Rakesh KB et al. ⁶, 21.86% by Pradhan S et al. ²³ & 63% by Kose E et al. ⁴⁸ Serious adverse drug reactions may occur as a consequence of inappropriate medication use.

For example, long-acting benzodiazepines like clonazepam can cause cognitive impairment and increase the risk of falls in elderly ¹⁹. In our study, 23.19% of patients received inappropriate drugs as per STOPP criteria which were in accordance with studies done by Lee SJ et al. ²² and O’Mahony D et al. ²⁰ showing their proportion as 20.5% and 21.4%, respectively. Among all prescriptions, 2.02% of prescriptions were underprescribed as per START criteria, whereas underprescription was found to be 26.5% in the study conducted by O’ Mahony D et al. ²⁰. We found the omission of the antiplatelet agent in some patients having a history of coronary artery disease and folic acid supplement in patients receiving Methotrexate as per START criteria. About 23.87% of patients received inappropriate prescriptions as per MAI criteria. This inappropriateness was significant in prescriptions with CKD. The proportion of inappropriateness by MAI criteria is comparable (19.9%) to the finding of Rakesh KB et al.⁶ This inappropriate prescription may increase the cost of therapy ³⁴.

CONCLUSION: In this study, there was a significant association between polypharmacy & comorbidities like diabetes, hypertension with diabetes, etc. Hypertension was the commonest comorbid condition. Inappropriateness was found in prescriptions having hypertension with diabetes and chronic kidney disease as comorbidities. Polypharmacy & inappropriate medications are related to various negative consequences like the risk of adverse drug effects, harmful drug interactions, non-adherence, and increased cost of therapy. The study's findings indicate that drugs should be selected more judiciously while prescribed for the elderly to prevent polypharmacy's ill effects.

Source(s) of Support: Nil

Presentation at a Meeting: Nil

Financial Support and Sponsorship: None

ACKNOWLEDGEMENT: Nil

CONFLICTING INTEREST: None

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    How to cite this article:

    Debnath S, Bhattacharjee P, Das L, Bhaumik D, Ghosh R and Datta A: A cross- sectional study on polypharmacy in elderly patients at a Tertiary Care Hospital of Tripura. Int J Pharm Sci & Res 2023; 14(3): 1319-29. doi: 10.13040/IJPSR.0975-8232.14(3).1319-29.

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